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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
not indicated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well-documented non-GLP study performed similar to OECD TG 405. No 21-day observation period.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No 21d observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Aminoxid WS 35
- Substance type: clear aqueous solution
- Physical state: liquid
- Analytical purity: 10% active material
- Other: pH 8.0

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.4-2.6 kg
- Housing: individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C
- Humidity (%): 50-60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: 1 animal showed grade 1 on day 4 and 5
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48, 72h
Score:
1.39
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48, 72h
Score:
0.33
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: 1 animal showed grade 1 on days 4-7
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
6 animals
Time point:
other: 24, 48, 72h
Score:
0.39
Max. score:
4
Reversibility:
fully reversible within: 2 days
Irritant / corrosive response data:
In 5 of 6 animals all effects were reversible within 5 days. In 1 animal iris effects appeared on day 4 and 5 (grade 1) and chemosis appeared on days 4-7, which was not reversible.
Other effects:
No data

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Reversible skin effects were observed in 5 of the 6 animals. In 1 animal chemosis was observed which was not reversible. As there was no 21-day observation period, no conclusion can be drawn on the classification according to CLP and DSD.