Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., barium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 1 - July 10, 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Follows standard procedures accepted at the time of the study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSLA CFR 21 191.11

Deviations:

not specified

GLP compliance:

no

Remarks:

conducted prior to GLP regulations

Test material

Test material information

Constituent 1

Reference substance name:

barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)

EC Number:

939-718-2

Cas Number:

1474044-80-8

Molecular formula:

C28H44O3S.1/2Ba

IUPAC Name:

barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)

Test material form:

other: as solution in light paraffinic and naphthenic petroleum distillates

Details on test material:

Brown viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: The rabbits were prepared by clipping the skin of the trunk free of hair. Epidermal abrasions were made over a 2-3 cm2 area on each rabbit. The patches were secured with tape and covered with a plastic trunk band to prevent evaporation.

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

Six New Zealand Albino Rabbits, 2-3- 3.0 kg.

Details on study design:

The rabbits were prepared by clipping the skin of the trunk free of hair. Epidermal abrasions were made over a 2-3 cm2
area on each rabbit. Two, 2.5 cm2 gauze patches were placed on each rabbit. One patch was placed over the intact skin, the
second patch over the abraded skin. Fivetenths of a mil I il iter of test material was placed under each patch. The patches were
secured with tape and covered with a plastic trunk band to prevent evaporation. The rabbits were immobilized in head stocks for
24 hours at which time the patches were removed and the rabbits returned to their cages.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

>= 2.3

Max. score:

8

Reversibility:

no data

Irritant / corrosive response data:

See table below

Other effects:

No adverse effects reported.

Any other information on results incl. tables

Erythema and Eschar Formation	Exposure Time hours	Average Exposure Unit Value
Intact Skin	24	2.8
Do	72	1.7
Abraded Skin	24	3.0
Do	72	1.7
Edema Formation	Subtotal	9.2
Intact Skin	24	0
Do	72	0
Abraded Skin	24	0
Do	72	0
	Subtotal	0
	Total	9.2
	Primarl Irritation Score (Index)	2.3

The test material is a moderate primary skin irritant

Observations: No untoward reactions.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test material is a moderate primary skin irritant.

Executive summary:

Primary Skin Irritation (FHSLA, CFR Title 21, para. 191. 11) was conducted in rabbits with the test substance. Intact and abraded skin were evaluated. 0.5 ml of test material was applied and the treatment period was 24 hours.

Skin lesions were evaluated at 24 and 72 hours and scored in accordance with CFR Title 21, para. 191.11 and evaluated as follows:

Score

0.5 non-primary irritant.

0.6- 2.0 mild primary irritant.

2.1 - 5.0 moderate primary irritant.

6.0 or > severe primary irritant.

The primary irritation index was 2.3 indicating the the test material is a moderate primary skin irritant.