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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
June 02, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 2. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
yes
Remarks:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 10 - 13 weeks
- Weight at study initiation: 2.90 Kgs. (♂) and 2.21 Kgs. (♀)
- Housing: single housed in semi-barrier system.
- Diet: A commercial irradiated diet (Styles-Oxbid) was fed ad libitum.
- Water: Sterile filtered water was available at all times.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C. (± 1°)
- Humidity (%):50-70%
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):100 mg
Duration of treatment / exposure:
single instillation into the conjunctival sac
Observation period (in vivo):
1, 6, 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
2 females and 4 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal: 11
Time point:
other: 24, 48, 72 hours
Score:
ca. 1
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 13
Time point:
other: 24, 48, 72 hours
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal: 12
Time point:
other: 24, 48, 72 hours
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant.
Executive summary:

Method

The substance was tested for eye irritation according to "Hazardous Substances Regulations" under the U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965).

Results

The eyes of the experimental animals were examined and found normal prior to the test. 100 mg of the test compound were instilled into the conjunctival sac of the left eye. The eyelids were then held closed for 1 second. . The right eye served as a control. After 30 seconds the compound was, as far as possible, flushed out of the eyes of three of the rabbits with warm water for 1 minute. The rabbits were examined 1, 6, 24, 48 and 72 hours after application of the test compound and for any further period that was considered necessary. A slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. All eyes were normal by 48 hours (washed) and 72 hours (unwashed).

Results

Non irritant.