Benzenesulfonic acid, 4-hydroxy-, 2,6-dimethylphenyl ester

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23-29 November 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

Species and strain: CBA/J Rj mice
Source: ELEVAGE JANVIER
Route des Chènes Secs B.P. 4105
53940 LE GENEST-ST-ISLE, France
Hygienic level: SPF at arrival; standard housing conditions during the study
Justification of strain: On the basis of OECD Guideline, mice of CBA/Ca or CBA/J strain can be used. Females are used because the existing database is predominantly based on females.
Number of animals: 4 animals / group
Sex: Female, nulliparous, non pregnant
Age of animals at starting: 9 weeks old (age-matched, within one week)
Body weight range at starting: 19.6-20.7 grams (The weight variation in animals in the study did not exceed ± 20 % of the mean weight.)
Acclimatization time: 6 days

Animal health: Only healthy animals were used for the study. Health status was certified by the veterinarian.
Housing / Enrichment: Group caging / mice were provided with glass tunnel-tubes
Cage type: Type II. polypropylene / polycarbonate
Bedding: Bedding was available to animals during the study
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20.4 – 25.0 °C
Relative humidity: 31 - 70 %
Ventilation: 15-20 air exchange/hour
The temperature and relative humidity were recorded twice every day during the acclimatisation and experimental phases.
Room/Cabinet (non-radioactive phase): 244/3
Room/Cabinet (radioactive phase): 139 – 140

Vehicle:

acetone/olive oil (4:1 v/v)

Concentration:

10, 25 and 50 % w/v

No. of animals per dose:

4

Details on study design:

A Preliminary Irritation/Toxicity Test was performed on CBA/J Rj mice using two doses (2 animals/dose), at test item concentrations of 50 and 25 (w/v) % in AOO. The preliminary experiment was conducted in a similar experimental manner to the main study, but it was terminated on Day 6 with a body weight measurement and the radioactive proliferation assay was not performed.
The maximum concentration of test item in an acceptable solvent was established according to OECD guideline 429. Based on the observation of the solubility test, the maximum available concentration was 50 (w/v) %.
In the Preliminary Irritation / Toxicity Test, all mice were observed daily for any clinical signs of systemic toxicity or local irritation at the application site. Both ears of each mouse were observed for erythema and scored using Table 2 [3]. Ear thickness was also measured using a thickness gauge on Day 1 (pre-dose), Day 3 (approximately 48 hours after the first dose) and Day 6. Additional quantification of the ear thickness was performed by ear punch weight determination after the euthanasia of the experimental animals.
During the study, animals were topically dosed with 25 μL of the appropriate formulation using a pipette on the dorsal surface of each ear. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Parameter:

SI

Remarks on result:

other: test article 50 (w/v) % in AOO: 0.8 test article 25 (w/v) % in AOO: 1.0 test article 10 (w/v) % in AOO: 0.9 Negative (vehicle) control: 1.0 Positive control (25 (w/v) % HCA in AOO): 8.7

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: test article 50 (w/v) % in AOO: 120.1 test article 25 (w/v) % in AOO: 166.4 test article 10 (w/v) % in AOO: 143.6 Negative (vehicle) control: 159.6 Positive control (25 (w/v) % HCA in AOO): 1390.1

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance was shown to have no sensitising potential (non sensitiser) in the Local Lymph Node Assay

Executive summary:

The sensitising potential has been assessed by topical application to the female mice in a suitable vehicle (Acetone/ olive oil 4:1 (w/v)) with a concurrent positive (HCA, 25% w/v in Acetone/ olive oil 4:1 (w/v) and solvent control in accordance with the OECD 429 test guideline in compliance with GLP. Under the conditions of the test in a suitable vehicle, the test substance was shown to have no sensitising potential (non sensitiser) in the Local Lymph Node Assay

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Migrated from Short description of key information:
Under the conditions of the test in a suitable vehicle, the test substance was shown to have no sensitising potential (non sensitiser) in the Local Lymph Node Assay

Justification for selection of skin sensitisation endpoint:
in vivo LLNA. K1 quality. Data generated in compliance with GLP

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The sensitising potential has been assessed by topical application to the female mice in a suitable vehicle (Acetone/ olive oil 4:1 (w/v)) with a concurrent positive (HCA, 25% w/v in Acetone/ olive oil 4:1 (w/v) and solvent control in accordance with the OECD 429 test guideline in compliance with GLP. Under the conditions of the test in a suitable vehicle, the test substance was shown to have no sensitising potential (non sensitiser) in the Local Lymph Node Assay