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

Endpoint summary

Description of key information

The test material is a moderate primary skin irritant, but not irritating to the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

other: FHSLA CFR 21 191.11

Deviations:

not specified

GLP compliance:

no

Remarks:

conducted prior to GLP regulations

Species:

rabbit

Strain:

New Zealand White

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.

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.

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.

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of eye irritation endpoint:
Not irritating based on EU criteria.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

The substance barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate) was found being irritant to skin but not irritant to eyes. Thus, it is classified as skin irritant, category 2 according to CLP (Regulation EC No 1272/2008). Data on respiratory irritation are not available.