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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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, results are indicative for irritation and represent a worst case (24 h exposure under occlusion). 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

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: not indicated
- Weight at study initiation: no data
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped and abraded
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 50%

Duration of treatment / exposure:
24 hours
Observation period:
scored at 24 and 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2 (two times, one for clipped skin, other for abraded skin)
- Type of wrap if used: occlusive, rubberized elastic cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
3
Remarks on result:
other: non-abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
3.5
Reversibility:
not reversible
Remarks on result:
other: non-abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24
Score:
2.83
Remarks on result:
other: non-abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
3
Reversibility:
not reversible
Remarks on result:
other: non-abraded skin
Irritant / corrosive response data:
irritant
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is irritating to the skin
Executive summary:

Six rabbits were exposed to the test substance dermally for 24 hours under occlusion. The test substance initiated irritation of the skin at 24 and 72 h observations. This irritation was not shown to be reversible. Therefore the test substance is classified as skin irritant category 2.

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