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EC number: 829-246-4 | CAS number: 34212-53-8
Endpoint summary
Administrative data
Description of key information
Irritation/corrosion:
- skin: not irritating
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 1h, 1d, 2d, 3d, 7d
- Number of animals:
- 4
- Details on study design:
-
SCORING SYSTEM:
Irritation was assessed and allocated a numerical value based on the following:
- Erythema and Eschar Formation
No erythema = 0;
Very slight erythema (barely perceptible) = 1;
Well-defined erythema = 2;
Moderate to severe erythema = 3;
Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4.
- Oedema Formation:
No oedema = 0;
Very slight oedema (barely perceptible) = 1;
Slight oedema (edges of area well-defined by definite raising) = 2;
Moderate oedema (raised approximately 1 mm) = 3;
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 0.92
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.08
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not qualified as irritating nor corrive according to the OECD TG 404.
Reference
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles, not according to current guidelines
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Internal BASF method was used
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 3.19 kg, female 3.44 kg - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: NaCl into other eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 100% - Duration of treatment / exposure:
- continuously
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- SCORING SYSTEM:
Gradings for corneal opacity, conjunctival redness and chemosis were converted into numerical grading system acc. to Draize.
Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe
Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe
4= very severe - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 72 h
- Score:
- 1.25
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24, 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- other: not specified for 48h
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.
Reference
Animal 1: male
Animal 2: female
Results:
| Readings | Animal | Erythema | chemosis | Corneal opacity | Additional findings |
| 1h | 1 | 2 | 1 | 1 | miosis |
| 2 | 2 | 3 | 2 | miosis | |
| 3 h | 1 | 2 | 1 | 1 | discharge |
| 2 | 2 | 2 | 2 | discharge | |
| 24 h | 1 | 1 | 1 | 2 | mucosal hemorrhages |
| 2 | 2 | 1 | 2 | mucosal hemorrhages | |
| 72 h | 1 | 1 | 0 | 1 | mucosal hemorrhages |
| 2 | 1 | 0 | 3 | mucosal hemorrhages, scar | |
| 4 d | 1 | 1 | 0 | 1 | mucosal hemorrhages |
| 2 | 1 | 0 | 3 | mucosal hemorrhages, scar | |
| 7 d | 1 | 1 | 0 | 1 | |
| 2 | 1 | 0 | 1 | scar | |
| 8 d | 1 | 1 | 0 | 1 | |
| 2 | 1 | 0 | 1 | scar | |
| Mean 24 - 72 h | 1 | 1 | 0.5 | 1.5 | |
| 2 | 1.5 | 0.5 | 2.5 | ||
| Mean | 1.25 | 0.5 | 2 |
No effects reported for iris.
No effects observed for eyes treated with NaCl.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
The present data on skin irritation do not fulfill the criteria laid down in CLP regulation, and therefore, the substance is not classified.
The present data on eye irritation fulfills the criteria laid down in CLP regulation.
Therefore, the substance can be classified as "irritating to eye" or "eye irritant" (category 2).
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