Ammonium (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

3

Remarks on result:

other: non-abraded skin

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

3.5

Reversibility:

not reversible

Remarks on result:

other: non-abraded skin

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24

Score:

2.83

Remarks on result:

other: non-abraded skin

Results 4

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.