Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Regulation under the Federal Hazardous Substance Labelling Act (February 1965) Part 191.12(b)(2)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

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: 3-5 months
- mean body weight at study initiation: males 2.90 kg and females 2.73 kg
- Housing: 6 rabbits were maintained under pretest conditions for one week prior to to the test.
- Diet: a commercial irradiated diet /Styles-Oxoid) was fed ad libitum
- Water: water was available at all times.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C
- Humidity: 50 - 70%
- Photoperiod (hrs dark / hrs light): animals were exposed to fifteen hours of artificial light from 08.00 hours to 23.00 hours daily.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 25 mg (= 0.1 mL bulk volume)
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
6
Details on study design:
- the test substance was applied into the conjunctival sac of the left eye. The eyelids were then closed for one second.
- the non-treated left eye served as control
- the test substance was not washed out

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
2
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h - 72h
Score:
0
Max. score:
3

Any other information on results incl. tables

Clinical Symptoms:

1 hour: Very mild ptosis present in one animal (male)

2. hours. Very mild ptosis present in one male and one female

4 hours: All animals normal and remained normal until autopsy

The nature of the material precluded any further detailed assessment at the times other than the examination of the lids and evidence of chemosis.

Autopsy:

No lesions attributed to the compound were found

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met