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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:
january 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: limited report, non GLP, effects were not shown to be reversible, The information in the report is limited to the information in the summary.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FHSLA 16 CFR 1500
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Lithium (di C8-C10, branched, C9 rich, alkylnaphtalene sulphonate)
IUPAC Name:
Lithium (di C8-C10, branched, C9 rich, alkylnaphtalene sulphonate)
Test material form:
liquid: viscous

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: individually
- Diet: Fisher Rabbit Pellets ad libitum
- Water: ad libitum
- Acclimation period: 18 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 50%

Observation period (in vivo):
scored 24, 48 and 72 hours after application
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: not indicated

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.3
Max. score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2.7
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 1.6
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 h
Score:
ca. 2.6
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
irritant

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance induced eye irritation
Executive summary:

Six rabbits were treated with the test substance in an eye irritation test. During the observation period of 72 hours severe eye irritation was reported, which was not shown to be reversible. In view of the absence of effects on the iris and a mean overall score of 1.3 for cornea, it was concluded that the test substance is a category 2 eye irritant.