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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study generally follows accepted procedures (Draize method) with an appropriate number of animals and dosing regime.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSLA. CFR Title 21, para. 191.11.

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

NASUL 729

IUPAC Name:

NASUL 729

Test material form:

liquid: viscous

Details on test material:

50% Calcium salt of Dinonylnaphthalene Sulfonic Acid (DNNSA)
50% light paraffinic and naphthenic petroleum distillates

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Fivetenths of a milliliter (0.5 ml) of test material was placed under each patch. The patches were
secured with tape and covered with a plastic trunk band to pjevent evaporation.

Duration of treatment / exposure:

The rabbits were immobil ized in head stocks for 24 hours at which time the patches were
removed and the rabbits returned to their cages.

Observation period:

Skin lesions were evaluated at 24 and 72 hours

Number of animals:

6

Details on study design:

The rabbits were prepared by cl ipping 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 second patch over the abraded skin. Five-tenths
of a mill il iter of test material was placed under each patch. The patches were secured with tape and covered with a plastic
trunk band to pjevent evaporation. The rabbits were immobil ized 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

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

average of 6

Time point:

other: 72

Score:

ca. 8.99

Reversibility:

no data

Remarks on result:

other: see attached tables for details

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72

Score:

ca. 0.66

Reversibility:

no data

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72

Score:

ca. 2.41

Reversibility:

no data

Irritant / corrosive response data:

See table.

Other effects:

No clinical symptoms reported.

Any other information on results incl. tables

Evaluation of Skin Reactions and Scoring Criteria

Erythema and Eschar Formation	Exposure Time hours	Average Exposure Unit Value
Intact Skin	24	1.83
	72	2.66
Abraded Skin	24	2.17
	72	2.33
Edema Formation	Subtotal	8.99
Intact Skin	24	0
	72	0.33
Abraded Skin	24	0
	72	0.33
	Subtotal	0.66
	Total	9.65
	Primary Irritation Score (Index)	2.41

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

NASUL 729 was determined to be a moderate skin irritant.

Executive summary:

NASUL 729 was evaluated for skin irritation following U.S. Federal Hazardous Substances Labeling Act (FHSLA) procedures. Rabbits were prepared by clipping the skin of the trunk free of hair. Epidermal abrasions were made over a 2-3 cm²area on each rabbit. Two, 2.5 cm²gauze patches were placed on each rabbit. One patch on the intact skin and a second patch over the abraded skin. Five-tenths of a milliliter (0.5) 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. Skin lesions were evaluated at 24 and 72 hours and scored. NASUL 729 had primary irritation score of 2.41 indicating moderate skin irritation.