Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

The study have been performed before the REACh legislation enters into force. This is the reason why only an in vivo experiment was performed.

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Laboratory study in experienced testing laboratory.

Justification for type of information:

Read Across to study conducted Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs EC 287-494-3, CAS 85536-14-7 considered scientifically justified due to structurally similarity.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

The study have been performed before the REACh legislation enters into force. This is the reason why only an in vivo experiment was performed.

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Laboratory study in experienced testing laboratory.

Justification for type of information:

Read Across to study conducted Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs EC 287-494-3, CAS 85536-14-7 considered scientifically justified due to structurally similarity.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Male and female white New Zealand rabbits weight between 4 and 5.6 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.

Number of animals:

6 (3 male, 3 female)

Details on study design:

The shaved treated area (about 6 m2) was covered with gauze and covered by polyethylene film for the first 4 hours, at which time the test area was rinsed with warm water. Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hours.

Score:

5.25

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: highly irritating

Other effects:

Significant reddening effects were observed at all times and were persistent. Bloody wounds and scar formation were observed through at least observation day 9.

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Result: Highly irritating

Executive summary:

The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the related substance benzenesulfonic acid, 4 -C10 -13 -sec-alkyl derivs and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

EC Number:

287-494-3

EC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.

Cas Number:

85536-14-7

Molecular formula:

SO3C7H8-(CH2)n with n= 9-12

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs

Details on test material:

Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Male and female white New Zealand rabbits weight between 4 and 5.6 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.

Number of animals:

6 (3 male, 3 female)

Details on study design:

The shaved treated area (about 6 m2) was covered with gauze and covered by polyethylene film for the first 4 hours, at which time the test area was rinsed with warm water. Observations were made after 1, 24, 48, 72 hours and 6, 9, and 14 days.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: Mean of 1, 24, 48 and 72 hours.

Score:

5.25

Max. score:

6

Reversibility:

not reversible

Remarks on result:

other: highly irritating

Other effects:

Significant reddening effects were observed at all times and were persistent. Bloody wounds and scar formation were observed through at least observation day 9.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Result: Highly irritating

Executive summary:

The shaved backs of three male and three female rabbits were exposed for 4 hours to 0.5 ml of the related substance benzenesulfonic acid, 4 -C10 -13 -sec-alkyl derivs and observed for up to 14 days. Significant reddening was observed throughout at least day 9. Swelling was perceptible throughout and appeared to become more noticeable with time. Bloody wounds and scar formation were observed through at least observation day 9. The test substance is considered highly irritating to the skin of rabbits.