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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Housing: individually housed in metal cages elevated above the droppings

- Diet: Purina rabbit chow, ad libitum

- Water: tap water, ad libitum


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): unspecified
- Concentration (if solution): undiluted
Duration of treatment / exposure:
24 hours (single instillation, not washed)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed



Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
26.7
Max. score:
20
Irritant / corrosive response data:
Mild to moderate erythema of the palpebral and bulbar conjunctivae , mild to moderate chemosis, mild mucoid discharge and a mild to moderate corneal opacity involving one-fourth to three-fourths of the corneal surface. By 72 hours, all test eyes showed improvement in the parameters of irritation in all but one animal. That one animal became worse and even developed mild iritis.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

60 min

0/0/0/0/0/0

0/0/0/0/0/0

 4/6/4/6/6/4

24 h

 5/30/30/20/5/20

0/0/0/0/0/0 

 4/10/10/10/8/8

48 h

 0/30/10/10/0/20

 0/0/0/0/0/0

 4/10/10/10/4/8

72 h

 0/40/5/5/0/5

 0/5/0/0/0/0

 2/14/4/8/2/4

Average 24h, 48h, 72h

          13.05

            0.3 

 7.2

 

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The data suggests that if interpreted in terms of EU criteria, the test substance would be a category 2 eye irritant.