5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide

Endpoint summary

Description of key information

ACDMA is non-irritant to rabbit skin in in vivo test performed according to OECD TG 404 & GLP following CLP criteria.

ACDMA is non-irritant to rabbit eye in in vivo test performed according to OECD TG 405 & GLP following CLP criteria.

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:

1987 November 3 to 6

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1981)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K. and Rosemead Rabbits, Ilaltham Abbey, Essex, U.K
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.42-2.76 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K. ) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water and food (Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K. ) was allowed throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 48-50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
A quantity of 0.5g of the test material moistened with 0.5 m1 of distilled water was introduced under a 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The patch was secured in position over the test material with a strip of surgical adhesfve tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals from interfering with the patches the trunk of each rabbit was wrapped in an elasticated
corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4h


OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1; 24; 48 & 72h after removal of the patches

SCORING SYSTEM:
- Method of calculation: Draize (1959) in the original report.

Irritation parameter:

erythema score

Basis:

animal: #1; 2 & 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1d (score of 1 observed after 1h in 3/3 animals)

Irritation parameter:

edema score

Basis:

animal: #1; 2 & 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 1d (score of 1 observed after 1h in 2/3 animals)

Interpretation of results:

GHS criteria not met

Conclusions:

ACDMA is non-irritant to rabbit skin in in vivo test performed according to OECD TG 404 & GLP following CLP criteria.

Executive summary:

ACDMA is non-irritant to rabbit skin in in vivo test performed according to OECD TG 404 & GLP following CLP criteria.

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:

1987: November 9 to 13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Waltham Abbey, Essex, U.K. and Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U.K
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.50-3.06 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet (e.g. ad libitum): Free access to mains drinking water and food (rabbit Diet, Preston Farmers Limited' New Leake, Boston, Linco'lnshire, u.K.) was allowed throughout the study.
- Water (e.g. ad libitum): Free access to mains drinking water and food (rabbit Diet, Preston Farmers Limited' New Leake, Boston, Linco'lnshire, u.K.) was allowed throughout the study.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 45-50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (corresponding to colume of 0.09 mL when gently compacted into an adapted syringe

Duration of treatment / exposure:

The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material from the eye, and then released.

Observation period (in vivo):

72h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
none
SCORING SYSTEM: Draize (1959)

Irritation parameter:

cornea opacity score

Basis:

animal: #1; 2 & 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not relevant in absence of symptoms after 1; 24; 48 & 72h

Irritation parameter:

iris score

Basis:

animal: #1; 2 & 3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 1h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 48h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 48/72h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 48h

Irritation parameter:

conjunctivae score

Basis:

animal: #2 & 3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24h (considering score of 2 after 1h for these 2 animals)

Irritation parameter:

chemosis score

Basis:

animal: #1; 2 & 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24h (for 2 animals considering score of 1 after 1h) and not relevant for animal (with score of 0 after 1h)

Interpretation of results:

GHS criteria not met

Conclusions:

ACDMA is non-irritant to rabbit eye in in vivo test performed according to OECD TG 405 & GLP following CLP criteria.

Executive summary:

ACDMA is non-irritant to rabbit eye in in vivo test performed according to OECD TG 405 & GLP following CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)