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EC number: 292-222-1 | CAS number: 90583-23-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 August - 14 September 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only limited information regarding test substance and test animals available and no iris score reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- not stated
- Deviations:
- yes
- Remarks:
- no iris score is reported
- GLP compliance:
- no
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts
- EC Number:
- 292-222-1
- EC Name:
- Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts
- Cas Number:
- 90583-23-6
- Molecular formula:
- Not applicable, UVCB substance
- IUPAC Name:
- Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Kleinrusse Chbb:HM
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Age at study initiation: young adult
- Weight at study initiation: 2482.5 g (mean of all 4 animals)
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 10% concentration of test substance in water - Duration of treatment / exposure:
- single application without washing
- Observation period (in vivo):
- 21 days
Reading time points: 1, 6, 24, 48 and 72 h and 7, 10, 14, 17, and 21 days - Number of animals or in vitro replicates:
- 4 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed/rinsed off after instillation of test substance
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 4 animals
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days in 2 animals
- Remarks:
- fully reversible within 7 - 14 days in 2 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of animals #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days in 1 animal
- Remarks:
- fully reversible within 14 days in 1 animal
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of animals #1 and #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Although no data on iritis (iris score) is reported, the available data on eye irritiation / damage is unambiguous and sufficient to derive a reliable classification and labelling.
- Irritant / corrosive response data:
- Individual corneal, conjunctivae and chemosis scores are summarised in the table in section “Any other information on results incl. tables”. No data are available regarding iritis. The test substance caused a slight corneal reactions in all animals (score 1). While the corneal reactions were fully revesible within 7 - 14 in 2 of the animals, they persisted until the end of the observation period after 21 days in the remaining 2 animals. The test substance also induced conjunctivae reactions. Moderate redness of the conjuntivae (score 2) was observed in 2 of the 4 animals which was fully revesible within 7 days. Redness (mean score 2.3 of 2/4 animals) of the conjunctivae was also visible in the other 2 animals with full reversion of the effect on day 21 of the observation period. Swelling (chemosis) of the conjuctivae was another effect observed after exposure to the test substance. While 2/4 animals exhibited only slight chemosis (max. score 1) that was fully reversible within 72 h after exposure, the effect lasted until day 7 in 1 animal and until day 10 in the remaining animals.
- Other effects:
- No further local or systemic effects were observed.
Any other information on results incl. tables
Table 1: Results of eye irritation test in rabbits after application of Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (10% active substance)
Rabbit No. / sex |
Scoring* after |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
1 |
1 h |
0 |
no data |
1 |
1 |
|
24 h |
1 |
no data |
2 |
1 |
|
48 h |
1 |
no data |
2 |
1 |
|
72 h |
1 |
no data |
2 |
0 |
|
7 d |
1 |
no data |
0 |
0 |
|
14 d |
0 |
no data |
0 |
0 |
|
21 d |
0 |
no data |
0 |
0 |
Individual mean (24, 48, 72 h) |
1.0 |
|
2.0 |
0.7 |
|
2 |
1 h |
0 |
no data |
1 |
1 |
|
24 h |
1 |
no data |
2 |
1 |
|
48 h |
1 |
no data |
2 |
1 |
|
72 h |
1 |
no data |
2 |
0 |
|
7 d |
0 |
no data |
0 |
0 |
|
14 d |
0 |
no data |
0 |
0 |
|
21 d |
0 |
no data |
0 |
0 |
Individual mean (24, 48, 72 h) |
1.0 |
|
2.0 |
0.7 |
|
3 |
1 h |
0 |
no data |
1 |
2 |
|
24 h |
1 |
no data |
2 |
1 |
|
48 h |
1 |
no data |
3 |
1 |
|
72 h |
1 |
no data |
2 |
1 |
|
7 d |
1 |
no data |
2 |
0 |
|
14 d |
1 |
no data |
2 |
0 |
|
21 d |
1 |
no data |
2 |
0 |
Individual mean (24, 48, 72 h) |
1.0 |
|
2.3 |
1.0 |
|
4 |
1 h |
0 |
no data |
1 |
2 |
|
24 h |
1 |
no data |
2 |
2 |
|
48 h |
1 |
no data |
3 |
1 |
|
72 h |
1 |
no data |
2 |
1 |
|
7 d |
1 |
no data |
2 |
1 |
|
14 d |
1 |
no data |
0a |
0 |
|
21 d |
1 |
no data |
0a |
0 |
Individual mean (24, 48, 72 h) |
1.0 |
|
2.3 |
1.3 |
|
*Scoring according to Draize scheme
aconjunctival blood infiltration observed
Applicant's summary and conclusion
- Interpretation of results:
- other: Eye damage 1, H318. Classification according to Regulation (EC) No 1272/2008 (CLP/EU GHS)
- Conclusions:
- Due to the irreversible nature of the corneal reactions (opacity score 1 after 21 days in 2/4 animals), the test substance has to be classified as eye damage 1, H318, according to Regulation (EC) No 1272/2008 (CLP). Although no data on iritis (iris score) is reported, the available data on eye irritiation / damage is unambiguous and sufficient to derive a reliable classification and labelling.
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