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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:
key study
Study period:
6.-10.12.1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Federal Register Vol 38, no 187, S. 27019, 1973
GLP compliance:
no
Remarks:
conducted prior to GLP guideline implementation

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, own breeding strain
- Strain: SPF-Albino-Himalayan, Hoe HIMK(SPFWiga)
- Housing: single cage
- Diet: ERKA 8300, ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eyes served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h after beginning of treatment
Number of animals or in vitro replicates:
6
Details on study design:
One time application of the substance to the conjunctival sac of the left eye of each animal, the right eye served as control respectively

- Washing: Washing with physiological saline 24 h after administration

- Tool to assess score after 48 and 72 h: 0.01 % solution of fluorescein sodium, under UV light

The eyes are examined and the grade of ocular reaction is recorded at 1, 7, 24, 48, and 72 hours.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
21
Max. score:
110
Reversibility:
not specified
Remarks on result:
other: slightly irritant
Irritant / corrosive response data:
In view of the shortened observation period and the slightness of effects a full recovery is expected in the case of a prolonged observation period of 21 days according to effective guidelines.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Classification acc. to (EC) 1272/2008: not irritating

This conclusion is legitimate since the test conditions are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points.
Executive summary:

Test material was subject to a test of eye irritancy similar to OECD Guideline 405. 100 mg of substance were applied to one eye of six animals. Mean values of the 24, 48 and 72 h readings after beginning of treatment were calculated for each animal. Only slight effects (conjunctival redness mean score: 1.4; chemosis mean score: 0.4; corneal opacity mean score: 0.4; iridial effects mean score: 0) below

the threshold for classification were determined. All effects were fully reversible or expectded to be fully reversible. Based on these findings the test material was judged not to be irritating to the eye.