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:
1979-03-12 to 1979-03-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented non-GLP study performed similar to OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Details described in study specific records
Specific details on test material used for the study:
- Name of test material (as cited in study report): none used
- Sample number: 4236-21-35
- Substance type: Clear liquid
- Physical state: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: local supplier
- Housing: The rabbits were housed two per cage in suspended wire mesh cages in temperature controlled room reserved exclusively for rabbits on acute tests.
- Diet (e.g. ad libitum): Fresh Purina Rabbit Chow was freely available
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 week

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye of each rabbit served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
No data; no washing after 24h
Observation period (in vivo):
The ocular reactions were graded at 1, 24, 48 and 72 hours and again at 7 days. If any corneal score was present on day 7, the eyes were scored again at 14 days.
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
SCORING SYSTEM: Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
45.8
Max. score:
110
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 48 hours
Score:
48.6
Max. score:
110
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 72 hours
Score:
67.8
Max. score:
110
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 14 days
Score:
42.4
Max. score:
110
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
maximum mean total score (MMTS) measured instead
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
maximum mean total score (MMTS) measured instead
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
maximum mean total score (MMTS) measured instead
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Remarks:
maximum mean total score (MMTS) measured instead
Irritant / corrosive response data:
Irritant response defined as 4 to 6 rabbits with positive scores.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
The substance is defined as irritant to the eyes as 4 to 6 rabbits were observed to have positive scores. Based on these results and the fact that the substance is corrosive to the skin, the substance is classified as causing serious eye damage to eyes (category 1) according to CLP Regulation.