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

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

0

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

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

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

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72h

Score:

0

Max. score:

0

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 h

Score:

>= 1 - <= 2

Max. score:

2

Reversibility:

fully reversible

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
in vivo skin irritation test. K1 quality. Data generated in compliance with GLP

Justification for selection of eye irritation endpoint:
in vivo eye irritation test. K1 quality. Data generated in compliance with GLP

Justification for classification or non-classification

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.

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 of 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.