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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:
July 28, 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
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), with slight modification.
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

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: average body weights of 2.73 kg (males) and 2.38 kg (females)
- Housing:The rabbits were caged singly in an experimental room.
- Diet (e.g. ad libitum):A commercial irradiated diet (Styles-Oxoid) was fed ad libitum.
- Water (e.g. ad libitum):Sterile filtered water was available at all times.
- Acclimation period: Six rabbits were acclimatised in the test area for one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- 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:
other: The right eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit) : 100 mg.
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
Six rabbits (3 males and 3 females)
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.

SCORING SYSTEM: the ocular reactions were scored by the method described in "Appraisal of the Safety of Chemicals in Food Drugs and Cosmetics" page 51, published by the Association of Food and Drug Officials of the U.S.A.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redeness
Basis:
animal: 15
Time point:
24/48/72 h
Score:
ca. 0.33
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: washed eyes
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 14, 16
Time point:
24/48/72 h
Score:
ca. 0.66
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: washed eyes
Irritation parameter:
chemosis score
Basis:
animal: 14, 15, 16
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
0
Reversibility:
other: no symptoms
Remarks on result:
other: washed eyes
Irritant / corrosive response data:
A slight to moderate conjunctival reaction was seen in all treated eyes one hour after application of the compound. This had subsided slightly by 24 hours and thereafter continued to do so until all eyes were normal by 48 hours (1/3 washed) 72 hours (2/3 unwashed 2/3 washed) and 6 days (1/3 unwashed). Staining of the conjunctivae and cornea by the compound was seen in the unwashed eyes for up to 40 hours.
Other effects:
None

Any other information on results incl. tables

Rabbit eye irritation scores-reference procedure:

    1 hour   6 hours   1 Day   2 Days   3 Days   6 Days
Rabbit No 11 13 15 12 14 16   11 13 15 12 14 16   11 13 15 12 14 16   11 13 15 12 14 16   11 13 15 12 14 16   11 13 15 12 14 16
Conjuctivae
A Redness 2 2 2 2 1 1   - - - - - -   1 2 1 2 1 1   1 1 - 1 1 1   - 1 - - - -   - - - - - -
B Chemosis 2 2 1 2 1 2   - - - - - -   1 1 - 1 - -   1 1 - 1 - -   - - - - - -   - - - - - -
C Discharge 2 1 - 3 - -   - - - - - -   - - - - - -   - - - - - -   - - - - - -   - - - - - -
c=(A+B+C) X2  (max. 20) 12 10 6 14 4 6   - - - - - -   4 6 2 6 2 2   4 4 - 4 2 2   - 2 - - - -   - - - - - -
Total   (Max.110) 12 10 6 14 4 6   - - - - - -   4 6 2 6 2 2   4 4 - 4 2 2   - 2 - - - -   - - - - - -

Eyes washed in Nos. 14, 15 & 16 hours

Applicant's summary and conclusion

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

Method

The study was performed to determine the eye irriattion potential of the test substance in rabbits according to the procedure set out in the "Hazardous Substances Regulations" under the U.S.A. "Federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965), with slight modification.

Conclusion

Not irritant