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EC number: 255-037-7 | CAS number: 40690-89-9
- 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
Not skin or eye irritating
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:
- 18 August 1998 to 21 August 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH
Number of animals: 3
Body weight at start of the study: 2.8-3.0 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20±3°C
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: 1 week under study conditions
Food: ssniff® K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: sesame oil
- Controls:
- no
- Amount / concentration applied:
- Dose levels: 500 mg per patch
Each animal was treated with 0.5 g test substance pasted with 1.0 ml sesame oil (Oleum sesami DAB 10). - Duration of treatment / exposure:
- Exposure 4 hours
- Observation period:
- 72 hours after removal of patch
- Number of animals:
- 3
- Details on study design:
- About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g test substance pasted with 1.0 ml sesame oil (Oleum sesami DAB 10). The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- no indication of irritation
- Remarks:
- skin discoloured orange
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- no indication of irritation
- Remarks:
- skin discoloured orange
- Irritant / corrosive response data:
- The reversibility results detailed correspond to minor skin discolouration. No other effects were noted. Three days after removal of the patch the irritations were reversible
- Other effects:
- From one hour up to one day after removal of the patch the skin surface of the animals was discoloured orange.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study the test substance is not irritating to skin.
- Executive summary:
The present study was conducted in compliance with EEC-Guideline B.4."Acute Toxicity Skin Irritation" of the Directive 92/69/EEC: Commission Directive of July 31,1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances and OECD Guidelines for Testing of Chemicals, 404 „Acute Dermal Irritation / Corrosion", updated guideline, adopted: July 17,1992
From one hour up to one day after removal of the patch the skin surface of the animals was discolored orange.
Three days after removal of the patch the irritations were reversible
Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated as zero. No effects other than skin staining were noted.
The substance is not considered to be an irritant to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978
- 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution): 50% (w/w) - Duration of treatment / exposure:
- One exposure at 0 h
- Observation period:
- min. 8 d, parameters observed at 24 and 72 h
- Number of animals:
- 6
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not irritating
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Remarks on result:
- not determinable
- Remarks:
- The substance stained the skin so that erythema could not be determined properly
- Irritation parameter:
- erythema score
- Basis:
- animal: 2, 3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritation observed
- Remarks on result:
- not determinable because of methodological limitations
- Remarks:
- average score based on two animals only since staining of skin was to strong to derive an appropriate erythema score
- Irritant / corrosive response data:
- Scarified skin showed a stronger edema score (1 out of 4, average of 24 and 72 h) but this method is not useful for classification according to CLP criteria. All irritation symptoms on scarified skin were fully reversible within 8 d.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on a skin irritation test with rabbits, the test substance is not irritating to skin. The average edema score was determined to be 0 (out of 4) on intact skin after 24 and 72 h.
Referenceopen allclose all
Generalised Results by Animal – Animals Against Parameters – Multiple Times
Activity : Skin Irritation Results
Study: 98.0574 – Skin Irritation Test in Rabbits
Group sex |
Animal Number |
Day Number |
Time Slot |
Bodyweight g |
Treated Flank |
Duration Treatment |
Erythema |
Edema |
1f |
313 |
1 |
|
2840 |
Left |
4 hours |
|
|
|
30-60 min. after decontamination |
|
|
|
0 |
0 |
||
2 |
24 hours after decontamination |
|
|
|
0 |
0 |
||
3 |
48 hours after decontamination |
|
|
|
0 |
0 |
||
4 |
72 hours after decontamination |
|
|
|
0 |
0 |
||
314 |
1 |
|
2800 |
Left |
4 hours |
|
|
|
|
30-60 min. after decontamination |
|
|
|
0 |
0 |
||
2 |
24 hours after decontamination |
|
|
|
0 |
0 |
||
3 |
48 hours after decontamination |
|
|
|
0 |
0 |
||
4 |
72 hours after decontamination |
|
|
|
0 |
0 |
||
315 |
1 |
|
2930 |
Left |
4 hours |
|
|
|
|
30-60 min. after decontamination |
|
|
|
0 |
0 |
||
2 |
24 hours after decontamination |
|
|
|
0 |
0 |
||
3 |
48 hours after decontamination |
|
|
|
0 |
0 |
||
4 |
72 hours after decontamination |
|
|
|
0 |
0 |
Nominal Dose: Group 1 – 0.5g (moistened)
Clinical Observations – Clinical Signs by Animal
Study: 98.0574 – Skin Irritation Test in Rabbits
Day numbers relative to Start Date |
||||||
Group Sex |
Animal Number |
Clinical Sign |
1 |
2 |
3 |
4 |
30-60 min a. decom. |
24 hours a. decom. |
48 hours a. decom. |
72 hours a. decom |
|||
1f |
313 |
No Abnormalities Detected |
- |
- |
X |
X |
|
Skin Discoloured- Small Area |
O |
O |
- |
- |
|
314 |
No Abnormalities Detected |
- |
- |
X |
X |
|
|
Skin Discoloured – Small Area |
O |
O |
- |
- |
|
315 |
No Abnormalities Detected |
- |
- |
X |
X |
|
|
Skin Discoloured – Small Area |
O |
O |
- |
- |
X = Present O = orange
Nominal Dose: Group 1 – 0.5g (moistened)
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:
- 25 August 1998 to 11 September 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH
Number of animals: 3
Body weight at start of the study: 3.1 -3.8 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20 ± 3eC
Relative humidity: 50 ± 20 %
Lighting time: 12 hours daily
Acclimatisation: 1 week under study conditions
Food: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Dose levels: 100 mg per eye, applied neat.
- Duration of treatment / exposure:
- 24 hours duration
- Observation period (in vivo):
- Initially 72 hours extended to 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
100 mg T-9601 was administered once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.
24 hours after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 hours after administration of the test substance. At 24 and 72 hours as well as after 7, 14 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of a 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2 and animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 7 days after application the irritations observed were all reversible.
- Other effects:
- From one hour up to 3 days after application the conjunctiva of the animal showed definitely injected blood vessels up to deeper crimson red colours and slight swellings up to swelling with partial eversion of lids. The irritations were attended by clear coloured eye discharge.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
- Executive summary:
Testing for primary irritation in the rabbit eye provides information on ocular lesions after a single administration of the test substance to the conjunctival sac of the eye and serves as a basis for classification and labelling.
The present study was conducted in compliance with EEC-Guideline B.5."Acute Toxicity Eye Irritation" of the Directive 92/69/EEC: Commission Directive of July 31,1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances and OECD Guidelines for Testing of Chemicals, 405 „Acute Eye Irritation / Corrosion", updated guideline, adopted: February 24, 1987.This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).
From one hour up to 3 days after application the conjunctiva of the animal showed definitely injected blood vessels up to deeper crimson red colours and slight swellings up to swelling with partial eversion of lids. The irritations were attended by clear coloured eye discharge.
7 days after application the irritations were reversible.
Based on the individual scores after 24, 48 and 72 hours, the following mean values were calculated:
Opacity of cornea
All animals
0.00
Iris
All animals
0.00
Animal 57
0.00
Animal 57
0.00
Animal 607
0.00
Animal 607
0.00
Animal 681
0.00
Animal 681
0.00
Redness of conjunctiva
All animals
0.89
Chemosis of conjunctiva
All animals
0.33
Animal 57
1.67
Animal 67
1.00
Animal 607
0.67
Animal 607
0.00
Animal 681
0.33
Animal 681
0.00
Testing for primary eye irritation in the rabbit showed, that the substance is not irritating to eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- one treatment at 0 h, observation at 24, 48 and 72 h
- Observation period (in vivo):
- min. 8 d
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 9.4
- Max. score:
- 80
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- other: not irritating
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 5.3
- Max. score:
- 20
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 14.78
- Max. score:
- 110
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- no indication of irritation
- Remarks:
- EU GHS
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- EU GHS
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- no indication of irritation
- Remarks:
- EU GHS
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 d
- Remarks on result:
- no indication of irritation
- Remarks:
- EU GHS
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Due to the low overall eye irritation score of 14.7 (mean of 24, 48 and 72 h) in rabbits, the classification criteria according to CLP were not met. The test substance showed only very weak signs of irritation (cornea opacity, conjunctivae) which were fully reversible within 8 d.
Referenceopen allclose all
Generalised Results By Animal – Animals Against Parameters – Multiple Times
Activity : - Eye Irritation Results
Eye Irritation Test in Rabbits
Group Sex |
Animal Number |
Day Number |
Time Slot |
Bodyweight g |
Treated Eye |
Control Eye normal |
Duration Treatment |
Initial Pain Reaction |
Eye Irrigated |
Fl.ceine staining |
Opacity Grade |
Opacity Area |
Iris |
Redness |
Chemosis |
Discharge |
1f |
57 |
1 |
Treatment |
3480 |
Left |
Yes |
24 hour |
None |
|
|
|
|
|
|
|
|
|
1 hour after treatment |
|
|
Yes |
|
|
No |
|
0 |
0 |
0 |
1 |
2 |
2 |
||
2 |
24 hours after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
2 |
2 |
1 |
||
3 |
48 hours after treatment |
|
|
Yes |
|
|
No |
|
0 |
0 |
0 |
2 |
1 |
0 |
||
4 |
72 hours after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
||
8 |
7 days after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
607 |
1 |
Treatment |
3180 |
Left |
Yes |
24 hour |
None |
|
|
|
|
|
|
|
|
|
|
1 hour after treatment |
|
|
Yes |
|
|
No |
|
0 |
0 |
0 |
2 |
2 |
2 |
||
2 |
24 hours after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
||
3 |
48 hours after treatment |
|
|
Yes |
|
|
No |
|
0 |
0 |
0 |
0 |
0 |
0 |
||
4 |
72 hours after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
681 |
1 |
Treatment |
3770 |
Left |
Yes |
24 hour |
None |
|
|
|
|
|
|
|
|
|
|
1 hour after treatment |
|
|
Yes |
|
|
No |
|
0 |
0 |
0 |
2 |
1 |
1 |
||
2 |
24 hours after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
||
3 |
48 hours after treatment |
|
|
Yes |
|
|
No |
|
0 |
0 |
0 |
0 |
0 |
0 |
||
4 |
72 hours after treatment |
|
|
Yes |
|
|
Yes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Nominal Dose: Group 1 – 0.1g
Clinical Observation – Clinical Signs by Animal
Eye Irritation Test in Rabbits
Day numbers relative to Start Date |
|||||||
Group Sex |
Animal Number |
Clinical Signs |
1 |
2 |
3 |
4 |
8 |
1 hour p. appl. |
24 hours p. appl. |
48 hours p. appl. |
72 hours p. appl. |
7 days p. appl. |
|||
1f |
57 |
No Abnormalities Detected |
X |
- |
X |
X |
X |
|
Eye discharge serous |
M |
S |
- |
- |
- |
|
607 |
No Abnormalities Detected |
- |
X |
X |
X |
- |
|
|
Eye discharge serious |
M |
- |
- |
- |
- |
|
681 |
No Abnormalities Detected |
- |
X |
X |
X |
- |
|
|
Eye discharge serious |
S |
- |
- |
- |
- |
X = Present S = slight M = Moderate
Nominal Dose: Group 1 – 0.1g
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation / Corrosion.
A single study was evaluated on this endpoint. In these the substance was tested for primary dermal irritation and corrosiveness. No inflammatory signs (eschar or oedema formation) became apparent within the observation period and signs of toxicity were not observed. Orange coloured staining was observed; however this was fully reversible within 3 days. This evidence indicates no hazard potential to the skin and the test substance may therefore be regarded as 'not irritating to the skin’. It is not a dermal corrosive. No risk phrase or classification is required.
Eye irritation.
A single study was evaluated on this endpoint. In these the substance was tested for acute irritation and was found not to be an irritant to the rabbit eye. Effects were noted in all animals assessed; however these were fully reversible within 24 hours. No classification is applicable.
Respiratory irritation
Respiratory irritation was not assessed; however no effects on the animals were noted in any associated studies.
Justification for classification or non-classification
The above studies have all been ranked reliability 1 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for irritation effects is therefore required.
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