Benzoic acid, 2-[[(4-hydroxyphenyl)sulfonyl]oxy]-, methyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10-13 January 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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

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:

methyl 2-[(4-hydroxybenzenesulfonyl)oxy]benzoate

Cas Number:

1432505-97-9

Molecular formula:

C14H12O6S

IUPAC Name:

methyl 2-[(4-hydroxybenzenesulfonyl)oxy]benzoate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft.
2173 Kartal, Császár út 135, HUNGARY
Justification of strain: The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test.
Number of animals: 3
Age of animals at treatment: ~13 weeks old
Sex: Male
Body weight range at the
beginning of the life phase: 3301-3530 g
at the end of the life phase: 3362-3588 g
Date of receipt: 21 December 2011
Acclimation time: 20 days
Animal identification: The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number.

Husbandry
Number of animal room: 620
Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature range during
the study: 20 ± 3 °C
Relative humidity during
the study: 26-62%
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages (65x65 cm with height of 45 cm). Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

The test item was used as supplied, as a single dose of 0.5 g JKY-270, applied to the test area. The untreated skin of each animal served as a control

Duration of treatment / exposure:

4 hours

Observation period:

Scoring at 1, 24, 48 and 72 hours after treatment

Number of animals:

3 male rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is non irritating to skin

Executive summary:

The primary skin irritation has been assessed by application to the clipped and shaved skin of three male rabbits in accordance with the OECD 404 test guideline in compliance with GLP. Following 4 hour semi-occluded exposure, skin reactions were recorded 1, 24, 48 and 72 h after exposure and resulted in no skin reactions. The substance is therefore not irritant to skin.