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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-23 June 2013

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:

1012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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 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. Both eyes of each animal provisionally selected for testing were examined prior to starting the study. Animals showing eye irritation, ocular defects or pre-existing corneal injury were not used.
Number of animals: 3 animals
Age of animals at treatment: 12 - 13 weeks old (young adult)
Sex: Male
Body weight range at the
beginning of the in-life phase: 3265 – 3319 g
end of the in-life phase: 3307 – 3456 g
Date of receipt: 01 June 2012
Acclimatization time: at least 5 days
Animal identification: The individual identification was by engraved ear tag. The cages were marked with individual identity cards with information about study code, sex, dose group, cage number and individual animal number.

Animal health: Only healthy animals were used for the test. The veterinarian certified health status.
Number of animal room: 620
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature
during the study: 20 ± 3°C
Relative humidity
during the study: 30 – 70 %
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. 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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

A single dose of 0.1 g of the solid test item

Duration of treatment / exposure:

The eyes of the test animals were washed out at 1 hour after application of test item.

Observation period (in vivo):

The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes.

Number of animals or in vitro replicates:

Three male animals

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance is not irritating to eyes.

Executive summary:

The acute eye irritation has been assessed by application to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP. Following exposure for 1 hour, the eyes were washed, eye reactions were recorded 1, 24, 48 and 72 h after exposure. All effects to the eyes were completelt reversible within 72 hours. The substance is therefore not irritant to eyes.