Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 15, 1985-Feb. 5, 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study done according to OECD guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, C10-13-alkyl derivs., calcium salts

IUPAC Name:

Benzenesulfonic acid, C10-13-alkyl derivs., calcium salts

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.5 kg
- Housing: individual cages, identified with ear tags
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum, 15 g/day
- Water (e.g. ad libitum): deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs

IN-LIFE DATES: From: Jan. 15, 1985 To: Feb. 5, 1985

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

4 hrs

Observation period:

Observations were made at 30-60 minutes, and 24, 48, and 72 hrs after end of exposure. If adverse effects had not resolved by the 72 hr observation, additional observations were made at 7, 14, and 21 days after end of exposure.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: 2.5 x 2.5 cm area
- Type of wrap if used: cellulose bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Though erythema cleared by 7 days, it reappeared at 14 days.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.8

Max. score:

2

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

From 1 to 72 hrs after end of exposure , animals showed mild to severe erythema, and mild to moderate edema. At the 7 day observation, there was on edema or erythema. However, at the 14 day observation, there was mild to moderate erythema, and the skin was raised, inflexible, and dry. At the 21 day oberservation, there was thickening of the epidermis, but a clearing of the erythema.

Other effects:

Microscopic examination showed hardening of the skin, hyperkeratosis, and misalignment with nearby skin.

Any other information on results incl. tables

Skin Irritation in Rabbits

Animal	Observation	Erythema and Scabbing	Edema
1	0.5-1 hr	1	3
	24 hrs	2	2
	48 hrs	2	1
	72 hrs	3	1
	7 days	0	0
	14 days	1	0
	21 days	Clearing of thickening and redness	-
2	0.5-1 hr	1	3
	24 hrs	2	2
	48 hrs	3	2
	72 hrs	3	2
	7 days	0	0
	14 days	2	0
	21 days	Clearing of thickening and redness	-
3	0.5-1 hr	2	3
	24 hrs	3	2
	48 hrs	3	2
	72 hrs	3	2
	7 days	0	0
	14 days	3	0
	21 days	Clearing of thickening and redness	-

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 skin according to the DSD and CLP.

Executive summary:

Three female rabbits were exposed to 0.5 ml of test substance on the dorsal area of the trunk for four hours. After four hours, the test substance was removed by washing with lukewarm water. Observations for erythema and edema were made 0.5 -1, 24, 48, and 72 hrs. Since adverse effects were not fully resolved by the 72 hr observation, further observations were made at 7, 14, and 21 days. Mild to moderately severe edema and erythema were noted at the 1, 24, 48, and 72 hr observations. Erythema and edema cleared by the 7 day observation, but the erythema returned by the 14 day observation. This was clearing by the 21 day observation. The test substance is classified as a Category 2 irritant according to EU DSD and CLP guidelines.