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EC number: 269-924-1 | CAS number: 68391-05-9 This substance is identified by SDA Substance Name: C12-C18 dialkyl dimethyl ammonium chloride and SDA Reporting Number: 16-047-00.
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Based on the results from the in vivo irritation studies, the test substance is considered to be corrosive to skin as well as eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From September 15, 1987 to September 29, 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL2 due to RA
- Justification for type of information:
- Refer to section 13 of IUCLID for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12-16 wk
- Weight at study initiation: 2.19 - 2.42 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: closely clipping the fur from the dorsal/flank areas using veterinary clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Undiluted
- Duration of treatment / exposure:
- Upto 60 min
- Observation period:
- The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Clipped dorsal flanks
- Type of wrap if used: Occlusive patches
- 0.5 mL of test material was applied under occlusive patches on the clipped dorsal flanks of three rabbits and left for 3 min application on one flank and 60 min application on the other flank.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in 3 % (v/v) aqueous acetic acid followed by cotton wool soaked in distilled water.
EVALUATION:
Approximately 1 h following removal of the patches and 24, 48 and 72 h and 7 and 14 d later, the test sites (a total of six) were examined for evidence of primary irritation and scored according to Draize (1959). - Irritation parameter:
- erythema score
- Remarks:
- (for 1 h exposure)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Eschar, moderate erythema extending beyond site, blanching of skin, scattered punctate formation
- Irritation parameter:
- edema score
- Remarks:
- (for 1 h exposure)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.56
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Oedema extending beyond site
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
- Interpretation of results:
- other: Category 1 (corrosive) based on EU CLP criteria
- Conclusions:
- Based on the results of the read across study, the test substance is considered to be corrosive to skin in rabbits.
- Executive summary:
A study was conducted to determine the skin irritation potential of the read across substance, DDAC (80% active in hydroalcoholic solution), according to the OECD Guideline 404, in compliance with GLP. In the study, 0.5 mL read across substance samples were applied under occlusive patches for both 3 and 60 min on the clipped skin of 3 rabbits. Residual read across substance was removed using cotton wool soaked in 3% (v/v) aqueous acetic acid followed by distilled water. The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d. After 3 min exposure, very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 ad 48 h observations and at two treated sites at the 72 h observation. On Day 7 and 14, some hyperkeratinisation (2/3) and desquamation (1/3) was still present.After 1 h exposure, a light brown discolouration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated skin sites 1 h after the removal of the patches. Blanching of the skin was also noted at two of the skin sites. Eschar had developed at all treated skin sites at the 24 h observation and continued to be noted at the 48, 72 h and Day 7 observations. Blanching and moderate erythema extending up to approximately 7 cm beyond the treatment site were also noted at all the treated skin sites during this period. Scattered punctuate eschar surrounding two of the skin sites was also noted, with dry, straw-coloured skin evident at all the sites on Day 7. On Day 14 sunken eschar was noted at all the treated skin sites. Severe oedema was noted at all the treated sites 1 h after the removal of the patches. The oedema gradually decreased and appeared as very slight to slight on Day 7. The oedema extended approximately 2 to 3 cm beyond all treated skin sites during this period. No oedema was noted on Day 14 (Guest, 1987). Based on the results of the read across study, the test substance is considered to be corrosive to skin in rabbits.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 15, 1987 to September 29, 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K.
- Age at study initiation: 12-16 wk
- Weight at study initiation: 2.19 - 2.42 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: closely clipping the fur from the dorsal/flank areas using veterinary clippers
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Undiluted
- Duration of treatment / exposure:
- Upto 60 min
- Observation period:
- The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Clipped dorsal flanks
- Type of wrap if used: Occlusive patches
- 0.5 mL of test material was applied under occlusive patches on the clipped dorsal flanks of three rabbits and left for 3 min application on one flank and 60 min application on the other flank.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in 3 % (v/v) aqueous acetic acid followed by cotton wool soaked in distilled water.
EVALUATION:
Approximately 1 h following removal of the patches and 24, 48 and 72 h and 7 and 14 d later, the test sites (a total of six) were examined for evidence of primary irritation and scored according to Draize (1959). - Irritation parameter:
- erythema score
- Remarks:
- (for 1 h exposure)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Eschar, moderate erythema extending beyond site, blanching of skin, scattered punctate formation
- Irritation parameter:
- edema score
- Remarks:
- (for 1 h exposure)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.56
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Oedema extending beyond site
- Irritant / corrosive response data:
- No data
- Other effects:
- No data
- Interpretation of results:
- other: Category 1 (corrosive) based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was found to be corrosive to skin in rabbits.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance, DDAC (80% active in hydroalcoholic solution), according to the OECD Guideline 404, in compliance with GLP. In the study, 0.5 mL test substance samples were applied under occlusive patches for both 3 and 60 min on the clipped skin of 3 rabbits. Residual test substance was removed using cotton wool soaked in 3% (v/v) aqueous acetic acid followed by distilled water. The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d. After 3 min exposure, very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 ad 48 h observations and at two treated sites at the 72 h observation. On Day 7 and 14, some hyperkeratinisation (2/3) and desquamation (1/3) was still present.After 1 h exposure, a light brown discolouration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated skin sites 1 h after the removal of the patches. Blanching of the skin was also noted at two of the skin sites. Eschar had developed at all treated skin sites at the 24 h observation and continued to be noted at the 48, 72 h and Day 7 observations. Blanching and moderate erythema extending up to approximately 7 cm beyond the treatment site were also noted at all the treated skin sites during this period. Scattered punctuate eschar surrounding two of the skin sites was also noted, with dry, straw-coloured skin evident at all the sites on Day 7. On Day 14 sunken eschar was noted at all the treated skin sites. Severe oedema was noted at all the treated sites 1 h after the removal of the patches. The oedema gradually decreased and appeared as very slight to slight on Day 7. The oedema extended approximately 2 to 3 cm beyond all treated skin sites during this period. No oedema was noted on Day 14. Under the study conditions, the test substance was found to be corrosive to skin in rabbits (Guest, 1987).
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From May 28, 1980 to June 4, 1980
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to guideline Association of Food and Drug Officials of the US, based on Draize, 1965 and pre-GLP. Not suitable for classification purposes due to aberrant exposure duration.
- Qualifier:
- according to guideline
- Guideline:
- other: Association of Food and Drug Officials of the US, based on Draize, 1965
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Pre GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, Penn. USA
- Age at study initiation: ca. 14 wk
- Weight at study initiation: 2509 - 2813 g
- Housing: Individually in screen bottom cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 14 d
IN-LIFE DATES: From: 28 May 1980 To: 4 June 1980 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Neat material - Duration of treatment / exposure:
- 24 h
- Observation period:
- After treatment, at 72 h (48 h after patch removal), and if signs of irritation had increased at 96 h (72 h after patch removal) and 7 d (6 d after patch removal).
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: Not indicated
- Area of coverage: 5.0 x 5.0 cm gauze patch
- Type of wrap if used: Saran wrap and elstoplast tape, plus collars
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test material was wiped (not washed)
- Time after start of exposure: After 24 h
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
A. Erythema and eschar formation
No erythema 0
Doubtful or barely perceptible 0.5
Very slight erythema 1
Slight not well defined 1.5
Well-defined erythema 2
Moderate 2.5
Moderate to severe erythema 3
Severe not beet red 3.5
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4
B. Oedema formation
No oedema 0
Doubtful or barely perceptible 0.5
Very slight oedema 1
Slight not well defined 1.5
Slight oedema (edges of area well-defined by
definite raising) 2
Edges well defined but less than 1 mm 2.5
Moderate oedema (raised approximately 1 mm) 3
Greater than 1 mm, exposure area only or 1 mm
extending beyond exposure area 3.5
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4 - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 3.75
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 3.42
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 3.92
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 3.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 3.92
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 3.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24/72 h
- Score:
- ca. 7.5
- Max. score:
- 8
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- - Blanching of the test sites was observed in all the animals at 24, 72 and 96 h readings (0, 48 and 72 h after patch removal).
- Five animals exhibited blanching of the test sites at 7 d.
- Subcutaneous hemorrhage was observed within the test sites of all animals at the 72 and 96 h and 7 d readings.
- Eschar formation was observed within the test sites of all animals at the 7 d observation - Other effects:
- None
- Interpretation of results:
- other: Category 1 (corrosive) based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was considered to be skin corrosive in rabbits.
- Executive summary:
A study was conducted to determine the skin irritation potential of the test substance, C12 -18 DAQ (75% active in hydroalcoholic solution) according to guideline of Association of Food and Drug Officials of the US, based on Draize, 1965. The test substance was applied to four test sites per rabbit (2 abraded and 2 intact) under an occlusive dressing for 24 h. Skin irritation was scored according to Draize, at patch removal, 72 and 96 h and 7 d later. Blanching of the test sites was observed in all of the animals at 24, 72 and 96 h. Five rabbits exhibited blanching of the test sites at 7 d. Subcutaneous haemorrhage was observed within the test sites of all animals at the 72 and 96 h and 7 d observations. Eschar formation was observed within the test sites of all animals at the 7 d observation. The primary dermal irritation index (the average of the 24 and 72 hour primary dermal irritation scores) was 7.5. Oedema scores on intact skins were 3.75, 4 at 24, 72 h and on abraded skins were 3.67, 3.92 at 24, 72 h, respectively. Erythema scores on intact skins were 3.42, 3.92 at 24, 72 h and on abraded skins were 3.5, 4 at 24, 72 h, respectively. Under the study conditions, the test substance was considered to be skin corrosive in rabbits (Thompson, 1980).
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
After three minutes exposure:
No adverse skin reaction were noted at any treated skin site 1 h after the removal of the patches. Very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 and 48 h observations and at two treated sites at the 72 h observation.
After one hour exposure:
A light brown discoloration of the epidermis and slight
haemorrhage of the dermal capillaries were noted at all treated skin
sites 1 h after the removal of the
patches. Blanching of the skin was also noted at two of the
skin sites. Eschar had developed at all treated skin sites at the 24
h observation and continued to be noted at the 48, 72 h and Day 7
observation. Blanching and moderate erythema extending up to
approximately 7 cm beyond
the treatment site were also noted at all the treated skin
sites during this period. Scattered punctate eschar
surrounding two of the skin sites was also noted, with dry,
straw-coloured skin evident at all the sites on Day 7. On Day 14
sunken eschar was noted at all the treated skin sites.
Severe oedema was noted at all the treated sites 1h
after the removal of the patches. The oedema gradually
decreased and appeared as very slight to slight on Day 7.
The oedema extended approximately 2 to 3 cm beyond
all treated skin sites during this period. No oedema was noted on Day
14.
For result tables, kindly refer to the attached background material section of the IUCLID.
After three minutes exposure:
No adverse skin reaction were noted at any treated skin site 1 h after the removal of the patches. Very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 and 48 h observations and at two treated sites at the 72 h observation.
After one hour exposure:
A light brown discoloration of the epidermis and slight
haemorrhage of the dermal capillaries were noted at all treated skin
sites 1 h after the removal of the
patches. Blanching of the skin was also noted at two of the
skin sites. Eschar had developed at all treated skin sites at the 24
h observation and continued to be noted at the 48, 72 h and Day 7
observation. Blanching and moderate erythema extending up to
approximately 7 cm beyond
the treatment site were also noted at all the treated skin
sites during this period. Scattered punctate eschar
surrounding two of the skin sites was also noted, with dry,
straw-coloured skin evident at all the sites on Day 7. On Day 14
sunken eschar was noted at all the treated skin sites.
Severe oedema was noted at all the treated sites 1h
after the removal of the patches. The oedema gradually
decreased and appeared as very slight to slight on Day 7.
The oedema extended approximately 2 to 3 cm beyond
all treated skin sites during this period. No oedema was noted on Day
14.
For result tables, kindly refer to the attached background material section of the IUCLID.
For result tables, kindly refer to the attached background material section of the IUCLID.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 27, 1980 to June 17, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoppers Unlimited, Verona, WI, USA
- Age at study initiation: ca. 14 wk
- Housing: Individually in screen bottom cages
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 7 d
IN-LIFE DATES: From: 28 May To: 17 June 1980 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated left eye of each animal served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): neat material - Duration of treatment / exposure:
- Two groups of animals were used, in one group (II) the eyes were washed after 30 sec exposure and in the other group the eyes were not washed (I). The study continued to 21 d
- Observation period (in vivo):
- Readings were done after 24, 48, 72 and 96 h and after 7, 14 and 21 d. At the 72 h, 7, 14 and 21 d reading sodium fluorescein and UV light were used.
- Number of animals or in vitro replicates:
- Group I: 6 animals
Group II: 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): in 3 out of 9 rabbits, the eyes of the other 6 remained unflushed.
- Time after start of exposure: ca. 30 sec
SCORING SYSTEM:
DRAIZE SCALE FOR SCORING OCULAR IRRITATION (1959)
1. CORNEA
(A) Degree of Opacity (most dense area used)
No opacity 0
Scattered or diffuse areas, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Opalescent areas, no details of iris visible, size of pupil barely discernible 3
Opaque, iris invisible 4
(B) Area of Cornea involved
One quarter (or less) but not zero 1
Greater than one quarter but less than half 2
Greater than half but less than three quarters 3
Greater than three quarters, up to whole area 4
THE TOTAL SCORE = (A x B) x 5, MAXIMUM TOTAL = 80
2. IRIS
(A) Values
Normal 0
Folds above normal, congestion, swelling, circumcorneal injection
(any or all of these or combination of any thereof), iris still reacting to light
(sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
THE TOTAL SCORE = A x 5, MAXIMUM TOTAL = 10
3. CONJUNCTIVAE
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal 0
Vessels definitely injected above normal 1
More diffuse, deeper crimson rad, indiviual vessels not easily discernible 2
Diffuse beefy red 3
(B) Chemosis
No swelling 0
Any swelling above normal (includes nictitating membrane) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids half closed to completely closed 4
(C) Discharge
No discharge 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to lids 2
Discharge with moistening of the lids and hairs and considerable area around the eye 3
THE TOTAL SCORE (A + B + C) x 2, MAXIMUM TOTAL = 20
MAXIMUM TOTAL SCORE POSSIBLE = 110
NB In this scoring system also half grades were used (0.5, 1.5, 2.5, or 3.5)
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 3.89
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: Unwashed eyes
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.33
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- (within 21 d)
- Remarks on result:
- other: washed eyes
- Irritation parameter:
- overall irritation score
- Remarks:
- unwashed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 99.1
- Max. score:
- 110
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- washed eyes
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 55.78
- Max. score:
- 110
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- - Blanching and areas of necrosis were observed in the conjunctivae of all rabbits at the 24, 48, 72, 96 h and 7 and 14 d readings and in 3 rabbits at 21 d.
- Hypopyon was observed in 4 rabbits at 7 d.
- Red ocular discharge was exhibited in 3 animals at 7 d and in 2 animals at 14 d.
- Panophthalmitis was exhibited by 1 animal at 14 days and by all animals at 21 days. - Other effects:
- None
- Interpretation of results:
- other: Category 1 (irreversible effects on the eye) based on EU CLP criteria
- Conclusions:
- Under the study conditions, the test substance was considered to be corrosive to eyes in rabbits.
- Executive summary:
A study was performed to determine the eye irritation potential of test substance, C12 -18 DAQ (75% active in hydroalcoholic solution), according to the method equivalent or similar to OECD 405. Two groups of New Zealand white rabbits were used to in the study. 0.1 mL test substance was instilled into the eye of 9 rabbits (leaving the other eye untreated as a control). In one group (with 3 animals) the eyes were washed after 30 sec exposure and in the other group (with 6 animals) the eyes were not flushed. Readings (according to Draize) were done after 24, 48, 72 and 96 h and after 7, 14 and 21 d. At the 72 h, 7, 14 and 21 d reading sodium fluorescein and UV light were used. Blanching and areas of necrosis were observed in the conjunctivae of all rabbits at the 24, 48, 72 and 96 h and 7 and 14 d readings and in three animals at 21 d. Hypopyon was observed in four animals at 7 d. Red ocular discharge was exhibited in three animals at the 7 d and two animals at 14 d. Panopthalmitis was exhibited by one animal at 14 d and by all animals at 21 d. Under the study conditions, the test substance was considered to be corrosive to eyes in rabbits (Thompson, 1980).
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
Table 1. Eye irritation scores (Draize) in rabbits exposed to 0.1 mL test substance and the eyes was not washed
Time |
Corneal Opacity |
Iris |
||||||||||
|
2997 |
2999 |
2947 |
3057 |
3051 |
3050 |
2997 |
2999 |
2947 |
3057 |
3051 |
3050 |
24 h |
4 |
3 |
4 |
3 |
4 |
4 |
2m |
2m |
2m |
2m |
2m |
2m |
48h |
4 |
4 |
4 |
4 |
4 |
4 |
2m |
2m |
2m |
2m |
2m |
2m |
72h |
4 |
4 |
4 |
4 |
4 |
4 |
2m |
2m |
2m |
2m |
2m |
2m |
96 h |
4 |
4 |
4 |
4 |
4 |
4 |
2m |
2m |
2m |
2m |
2m |
2m |
7 d |
3.5k |
3.5k |
m |
3.5k |
m |
3.5k |
2m |
2m |
2m |
2m |
2m |
2m |
14 d |
4 |
4 |
4 |
q |
4 |
4 |
2m |
2m |
2m |
2m |
2m |
2m |
21 d |
q |
q |
q |
q |
q |
q |
q |
q |
q |
q |
q |
q |
Mean 24-72 h |
4 |
3.67 |
4 |
3.67 |
4 |
4 |
2 |
2 |
2 |
2 |
2 |
2 |
Time |
Conjunctivae - Redness |
Conjunctivae - Chemosis |
Conjunctivae - Discharge |
|
||||||||||||||||||
2997 |
2999 |
2947 |
3057 |
3051 |
3050 |
2997 |
2999 |
2947 |
3057 |
3051 |
3050 |
2997 |
2999 |
2947 |
3057 |
3051 |
3050 |
|||||
24 h |
1 |
1 |
1 |
1 |
1 |
1 |
4 |
4 |
4 |
4 |
4 |
4 |
3a |
3a |
3a |
3a |
3a |
3a |
||||
48 h |
0jd |
0jd |
0jd |
0jd |
0jd |
0jd |
4 |
4 |
4 |
4 |
4 |
4 |
3a |
3a |
3a |
3a |
3a |
3a |
||||
72 h |
0jd |
0jd |
0jd |
0jd |
0jd |
0jd |
4 |
4 |
4 |
4 |
4 |
4 |
3a |
3a |
3a |
3a |
3a |
3a |
||||
96 h |
0jd |
0jd |
0jd |
0jd |
0jd |
0jd |
4 |
4 |
4 |
4 |
4 |
4 |
3a |
3a |
3a |
3a |
3a |
3a |
||||
7 d |
0 |
0 |
m |
0 |
m |
0 |
4 |
3.5 |
4 |
4 |
4 |
3.5 |
2a |
2.5a |
3pa |
3pa |
3a |
2.5pa |
||||
14 d |
2jd |
2jd |
2jdl |
ljdm |
2jdl |
2jdl |
4 |
4 |
4 |
4 |
4 |
4 |
3ap |
2a |
2a |
2a |
2a |
2ap |
||||
21 d |
2jd |
2jd |
m |
m |
m |
2.5 |
3 |
3.5 |
4 |
3 |
3.5 |
4 |
2.5a |
2a |
1a |
1a |
2a |
2a |
||||
Mean 24-72 h |
0.33 |
0.33 |
0.33 |
0.33 |
0.33 |
0.33 |
4 |
4 |
4 |
4 |
4 |
4 |
3 |
3 |
3 |
3 |
3 |
3 |
||||
a Purulent discharge
d Blanching
k hypopyon
l Hair loss around the eye
J Conjunctivae appear necrotic
m Unable to visualise
p red discharge
q Panopthalmitis
Table 2. Eye irritation scores (Draize) in rabbits exposed to 0.1 mL test substance and the eyes was flushed for one minute
Time |
Corneal Opacity |
Iris |
Conjunctivae - redness |
Conjunctivae- chemosis |
Conjunctivae- discharge |
|||||||||||
2958 |
2935 |
3018 |
2958 |
2935 |
3018 |
2958 |
2935 |
3018 |
2958 |
2935 |
3018 |
2958 |
2935 |
3018 |
||
24 h |
1.5 |
3 |
1.5 |
1inj |
2m |
1inj |
2jd |
2jd |
2jd |
4 |
4 |
4 |
3a |
3a |
3a |
|
48h |
1 |
3 |
1.5 |
1inj |
2m |
1inj |
2jd |
0jd |
1jd |
4 |
4 |
4 |
3a |
3a |
3a |
|
72h |
2 |
3 |
1.5 |
1inj |
2m |
1inj |
3jd |
3jd |
3jd |
4 |
4 |
4 |
3pa |
3a |
3a |
|
96 h |
1.5 |
4 |
1.5 |
1inj |
2m |
1inj |
3jd |
3jd |
3jd |
4 |
4 |
4 |
3pa |
3a |
3pa |
|
7 d |
3.5k |
4k |
3 |
1inj |
2m |
1inj |
3cjd |
0jd |
3cjd |
4 |
4 |
3.5 |
3a |
3a |
3a |
|
14 d |
4h |
4 |
4h |
2m |
2m |
2m |
2jd |
2jdl |
2cjd |
2 |
4 |
4 |
1.5a |
2a |
2a |
|
21 d |
4 |
q |
4 |
2m |
q |
2m |
2.5cjd |
2.5jd |
3.0kcjd |
3 |
4 |
3 |
3a |
2.5p |
3a |
|
Mean 24-72 h |
1.5 |
3 |
1.5 |
1 |
2 |
1 |
2.3 |
1.67 |
2 |
4 |
4 |
4 |
3 |
3 |
3 |
|
a Purulent discharge
c Petite hemorrhage
d Blanching
k Conjunctivae appears necrotic
j Conjunctivae appears necrotic
inj Injected
m Unable to visualise
p Red discharge
q Panopthalmitis
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A study was conducted to determine the skin irritation potential of the test substance, C12-18 DAQ (75% active in hydroalcoholic solution) according to guideline of Association of Food and Drug Officials of the US, based on Draize, 1965.The test substance was applied to four test sites per rabbit (2 abraded and 2 intact) under an occlusive dressing for 24 h. Skin irritation was scored according to Draize, at patch removal, 72 and 96 h and 7 d later. Blanching of the test sites was observed in all of the animals at 24, 72 and 96 h. Five rabbits exhibited blanching of the test sites at 7 d. Subcutaneous haemorrhage was observed within the test sites of all animals at the 72 and 96 h and 7 d observations. Eschar formation was observed within the test sites of all animals at the 7 d observation. The primary dermal irritation index (the average of the 24 and 72 hour primary dermal irritation scores) was 7.5.Oedema scores on intact skins were 3.75, 4 at 24, 72 h and on abraded skins were 3.67, 3.92 at 24, 72 h, respectively. Erythema scores on intact skins were 3.42, 3.92 at 24, 72 h and on abraded skins were 3.5, 4 at 24, 72 h, respectively. Under the study conditions, the test substance was considered to be skin corrosive in rabbits (Thompson, 1980).
Astudy was conducted to determinethe skin irritation potential of the read across substance, DDAC (80% active in hydroalcoholic solution), according to OECD Guideline 404, in compliance with GLP.In the study,0.5 mL read across substance samples were applied under occlusive patches for both 3 and 60 min on the clipped skin of 3 rabbits. Residual read across substance was removed using cotton wool soaked in 3% (v/v) aqueous acetic acid followed by distilled water. The skin was assessed immediately after removal of the patch and again at 24, 48 and 72 h, and at 7 and 14 d.After 3 min exposure, very slight or well-defined erythema had developed at two treated skin sites at the 24 h observation and continued to be noted at all the treated sites at the 48 and 72 h observations. Very slight oedema was noted at one treated site at the 24 ad 48 h observations and at two treated sites at the 72 h observation. On Day 7 and 14, some hyperkeratinisation (2/3) and desquamation (1/3) was still present.After 1 h exposure, a light brown discolouration of the epidermis and slight haemorrhage of the dermal capillaries were noted at all treated skin sites 1 h after the removal of the patches. Blanching of the skin was also noted at two of the skin sites. Eschar had developed at all treated skin sites at the 24 h observation and continued to be noted at the 48, 72 h and Day 7 observations. Blanching and moderate erythema extending up to approximately 7 cm beyond the treatment site were also noted at all the treated skin sites during this period. Scattered punctuate eschar surrounding two of the skin sites was also noted, with dry, straw-coloured skin evident at all the sites on Day 7.On Day 14 sunken eschar was noted at all the treated skin sites. Severe oedema was noted at all the treated sites 1 h after the removal of the patches. The oedema gradually decreased and appeared as very slight to slight on Day 7. The oedema extended approximately 2 to 3 cm beyond all treated skin sites during this period. No oedema was noted on Day 14 (Guest, 1987). Based on the results of the read across study, the test substance is considered to be corrosive to skin in rabbits.
Further, read across studies with C18 DAQ, which have been reviewed in the EU RAR (EU, 2002) are described below:
In a test with rabbits according to OECD guidelines 404, moderate skin irritation was detected for C18 DAQ (purity approx. 97%): Three albino rabbits were tested with 0.5 g of the substance pasted with isotonic saline using semi-occlusive patches. All animals revealed mild to moderate erythema (mean scores for 24, 48 and 72 observation periods: 2/1/0.3) that reversed within 14 days. In addition, the treated skin areas were sporadically dry-rough, discolored light brown and demonstrated fine or coarse scales during the observation period of 14 days. Edema were not seen (Hoechst AG 1986c, 1986d, unpublished reports).
Another study with technical grade C18 DAQ, containing 77% dimethyldioctadecylammonium chloride, 11.3% isopropanol and 11.7% water, however, caused corrosion after a 4-hours contact with the skin of rabbits: A test with 6 rabbits according to OECD 404 (semi-occlusive application of 0.5 ml for 4 hours) resulted in moderate irritation, the effects increased after the day of application till exhibition of severe necrosis after a 14-day observation time (Hoechst AG 1989a, unpublished report).
Overall, based on the available information, the test substance is considered to be corrosive to skin.
Eye irritation
A study was performed to determine the eye irritation potential of the test substance, C12 -18 DAQ(75% active in hydroalcoholic solution),according to the method equivalent or similar to OECD 405.Two groups of New Zealand white rabbits were used to in the study.0.1 mL test substance was instilled into the eye of 9 rabbits (leaving the other eye untreated as a control).In one group (with 3 animals) the eyes were washed after 30 sec exposure and in the other group (with 6 animals) the eyes were not flushed. Readings (according to Draize) were done after 24, 48, 72 and 96 h and after 7, 14 and 21 d. At the 72 h, 7, 14 and 21 d reading sodium fluorescein and UV light were used. Blanching and areas of necrosis were observed in the conjunctivae of all rabbits at the 24, 48, 72 and 96 h and 7 and 14 d readings and in three animals at 21 d. Hypopyon was observed in four animals at 7 d. Red ocular discharge was exhibited in three animals at the 7 d and two animals at 14 d. Panopthalmitis was exhibited by one animal at 14 d and by all animals at 21 d.Under the study conditions, the test substance was considered to be corrosive to eyes in rabbits (Thompson, 1980).
Justification for classification or non-classification
Based on the results of thein vivoskin irritation studies with the test and read across substances, the test substance warrants a corrosive, ‘Skin Corr. 1C; H314: Causes severe skin burns and eye damage’ as well as serious eye damage, ‘Eye dam. 1; H318: Causes serious eye damage’ classification according to EU CLP criteria (Regulation EC 1272/2008). Labelling for this endpoint is covered by the above classifications for skin effects.
With regard to respiratory tract irritation, although the dialkyl quats are very corrosive substances, the low vapour pressure prohibits occurrence of respiratory irritation by vapour. Further, the classification of corrosive is already considered to implicitly cover the potential of RTI and additional Cat.3 is considered to be superfluous (Guidance CLP Ch. 3.8.2.5).
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