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EC number: 407-410-2 | CAS number: -
- 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
GLP guideline studies in rabbits are available for skin and eye irritation according to OECD 404 and OECD 405, respectively.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-11-27 to 1990-12-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. An updated OECD guideline from 2002 is available; changes do not affect the reliability of this study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, UK
- Age at study initiation: No data
- Weight at study initiation: 3.5, 3.2, and 3.6 kg, all female
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet "Ssniff K 4", approx. 100-120 g per animal and day (fed in the morning)
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): Approx. 50 %
- Air changes (per hr): Approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12 (illumination from 6 to 18 hrs CET) - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg, moistened - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: semiocclusive dressing (Fixomull-Stretch Klebevlies, Beiersdorf no. 2293)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With water
- Time after start of exposure: 4 h
SCORING SYSTEM:
According to DRAIZE - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- No other effects.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Irritant and/or corrosive effects of TCD-emulsifier were tested according to OECD uideline 404 and EU Method B.4. The test substance is not irritating to rabbit skin.
- Executive summary:
In a primary dermal irritation study according to OECD guideline 404 and EU method B.4, adult albino rabbits (strain: HC:NZW) (3 female animals) were dermally exposed to 500 mg TCD-emulsifier in water for 4 hours, administered to 6 cm² at dorso-lateral areas of the animals' trunk. Animals then were observed for 7 days. Irritation was scored by the method of DRAIZE.
No irritation occurred. Based on the study results, TCD-emulsifier is not classified according to CLP Annex I as a dermal irritant.
Reference
Skin irritant effects of the TCD-emulsifier:
Animal No. |
Body weight [kg] |
Sex |
Draize grade after |
Irrit. index |
||||||||||||
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
|||||||||||
e |
o |
e |
o |
e |
o |
e |
o |
e |
o |
e |
o |
e |
o |
|||
L4 |
3.5 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
0.0 |
L6 |
3.2 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
0.0 |
K23 |
3.6 |
Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
0.0 |
e: erythema and eschar formation
o: oedema formation
-: not examined
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-11-27 to 1990-12-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. An updated OECD guideline 405 from 2012 is available; changes do not affect the reliability of this study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna U.K. Ltd., Wyton, Huntingdon, England
- Age at study initiation:
- Weight at study initiation: 3.5, 3.2, and 3.6 kg, all female
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): Standard diet "Ssniff K 4", approx. 100-120 g per animal and day (fed in the morning)
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): Approx. 50 %
- Air changes (per hr): Approx. 10/h
- Photoperiod (hrs dark / hrs light): 12/12 (illumination from 6 to 18 hrs CET) - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µl (approx. 40 mg) - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with saline
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize Grades
TOOL USED TO ASSESS SCORE: Hand-slit lamp, fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Erythema
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.2
- Max. score:
- 1.3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.1
- Max. score:
- 0.3
- Reversibility:
- fully reversible
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye irritant/corrosive potential of the test item was assessed in rabbits according to OECD guideline 405 and EU method B.5. The test substance induced slight reactions of the mucous membranes and mild corneal effects which were fully reversible within 7 days. The substance is regarded as slightly irritating.
- Executive summary:
In a primary eye irritation study in accordance with OECD guideline 405 and EU method B.5, 100 µl of TCD-emulsifier was instilled into the conjunctival sac of adult rabbits (strain: HC:NZW) (3 female) for 24 hours. The eyes were rinsed with saline after 24 h of exposure. Animals then were observed for 7 days. Irritation was scored by the method of DRAIZE.
The exposure induced slight reactions of the mucous membranes and mild corneal effects which were fully reversible within 7 days. Based on the study results, the test item is not classified as an eye irritant according to CLP Annex I.
Reference
Results for the grading of irritating effects on the eye:
Animal no./ Sex |
Body weight |
Tissue |
Signs |
DRAIZE grades |
Irritation index |
||||||
1 h |
24 h |
48 h |
72 h |
7 d |
14 d |
21 d |
|||||
M26/ Female |
2.7 kg |
Cornea |
o |
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
a |
0 |
0 |
0 |
0 |
0 |
- |
- |
|
|||
Fluorescein |
i |
- |
1 |
1 |
0 |
- |
- |
- |
|
||
a |
- |
1c |
1p |
0 |
- |
- |
- |
|
|||
Iris |
|
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
||
Conjunctivae |
r |
1 |
1 |
1 |
1 |
0 |
|
|
1.0 |
||
s |
1 |
0 |
0 |
0 |
0 |
|
|
0.0 |
|||
Aqueous humour |
|
0 |
0 |
0 |
0 |
0 |
- |
- |
|
||
Discharge |
|
1 |
0 |
0 |
0 |
0 |
- |
- |
|
||
M25/ Female |
2.9 kg |
Cornea |
o |
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
a |
0 |
0 |
0 |
0 |
0 |
- |
- |
|
|||
Fluorescein |
i |
- |
1 |
1 |
0 |
- |
- |
- |
|
||
a |
- |
2c |
1c |
0 |
- |
- |
- |
|
|||
Iris |
|
0 |
1 |
0 |
0 |
0 |
- |
- |
0.3 |
||
Conjunctivae |
r |
1 |
2 |
1 |
1 |
0 |
- |
- |
1.3 |
||
s |
2 |
1 |
0 |
0 |
0 |
|
|
0.3 |
|||
Aqueous humour |
|
0 |
0 |
0 |
0 |
0 |
- |
- |
|
||
Discharge |
|
3 |
0 |
0 |
0 |
0 |
- |
- |
|
||
K8/ Female |
3.4 kg |
Cornea |
o |
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
a |
0 |
0 |
0 |
0 |
0 |
- |
- |
|
|||
Fluorescein |
i |
- |
0 |
- |
- |
- |
- |
- |
|
||
a |
- |
0 |
- |
- |
- |
- |
- |
|
|||
Iris |
|
0 |
0 |
0 |
0 |
0 |
- |
- |
0.0 |
||
Conjunctivae |
r |
1 |
2 |
1 |
1 |
0 |
- |
- |
1.3 |
||
s |
1 |
0 |
0 |
0 |
0 |
|
|
0.0 |
|||
Aqueous humour |
|
0 |
0 |
0 |
0 |
0 |
- |
- |
|
||
Discharge |
|
1 |
0 |
0 |
0 |
0 |
- |
- |
|
o: Opacity
a: Area
i: Intensity
r: Redness
s: Swelling
-: Not examined
c: Confluent diffuse areas
p: Scattered punctate
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The results indicate that the test substance can be regarded as 'not irritating to the skin'.
Administration of the test substance to the eye caused slight reactions of the mucous membranes and mild corneal effects which proved to be fully reversible within 7 days. Therefore the test substance may be considered as 'slightly irritating to the eye' but does not fulfil the criteria of the CLP regulation for classification as eye irritant.
Effects on eye irritation: slightly irritating
Justification for classification or non-classification
The results indicate that the test substance can be regarded as 'not irritating to the skin'.
Exposure of the test substance to the eye caused slight reactions of the mucous membranes and mild corneal effects which proved to be fully reversible within 7 days. Therefore the test substance may be considered as ‘slightly irritating to the eye' but does not fulfil the criteria of the CLP regulation for classification as eye irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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