4-chloro-7H-pyrrolo[2,3-d]pyrimidine

Endpoint summary

Description of key information

Skin:

The skin irritation study is performed using rabbits according to OECD Guideline 404 under GLP. The test item is not irritating to rabbit skin.

Eye:

The eye irritation study is performed using rabbits according to OECD Guideline 405 under GLP. The test item is not irritating to rabbit eyes.

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:

From 20 Dec 2016 to 05 Jan 2017

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

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: Covance Research Products Inc., Denver, PA, on 07 Dec 2016.
- Age at study initiation: The male animals were born on 27 Aug 2016.
- Weight at study initiation: The pre-test body weight range was 2.6 -2.8 kg.
- Housing: The animals were identified by cage notation and a uniquely numbered metal ear tag and individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g test item per site and moistened with 1.0 ml of distilled water to form a pasty consistency.

Duration of treatment / exposure:

3 minutes, 1 hour, 4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 100%
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently washed with gauze saturated with distilled water following patch removal.
- Time after start of exposure: 3 minutes, 1 hour, 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 3 minutes, 1 hour, 24 hours, 48 hours, 72 hours

SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize scale.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Other effects:

Systemic Observations: No abnormal physical signs were observed.
Body Weights: All three animals gained weight by study termination.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to rabbit skin.

Executive summary:

The skin irritation study is performed using rabbits according to OECD Guideline 404 under GLP.

The test item is not irritating to rabbit 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:

From 05 Dec 2016 to 08 Dec 2016

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA on 02 Nov 2016
- Age at study initiation: The male animals were born on 09 Jul 2016 and/or 16 Jul 2016. The female animal was born on 16 Jul 2016.
- Weight at study initiation: The pre-test body weight range was 2.9 - 3.1 kg.
- Housing: The animals were individually housed in suspended wire-bottom cages. Absorbent paper bedding was placed beneath the cages and changed at least three times per week.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet No. 5321) was provided daily.
- Water (e.g. ad libitum): Water was available ad libitum.
- Acclimation period: at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml equivalent (60 mg)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

Three rabbits (two males - one female)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

SCORING SYSTEM: Ocular reactions were graded according to the numerical Draize technique.

TOOL USED TO ASSESS SCORE: Sodium fluorescein dye procedures were performed at the 24-hour observation interval. The eye was examined with the aid of an ultraviolet light source.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Other effects:

Systemic Observations: No abnormal physical signs were observed.
Body Weights: Two animals' gained weight and one animal lost weight by study termination.

Interpretation of results:

GHS criteria not met

Conclusions:

The test item is not irritating to rabbit eyes.

Executive summary:

The eye irritation study is performed using rabbits according to OECD Guideline 405 under GLP. The test item is not irritating to rabbit eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion:

In vivo skin irritation, key study, OECD 404:

Mean score for erythema at 24, 48, 72 h for 3 tested animal: 0, 0, 0

Mean score for edema at 24, 48, 72 h for 3 tested animal: 0, 0, 0

According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.

 

Eye irritation:

In vivo eye irritation, key study, OECD 405:

Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:

cornea opacity: 0, 0, 0;

iris: 0, 0, 0;

conjunctivae: 0.33, 0.33, 0.33;

chemosis: 0.33, 0, 0.

According to Regulation (EC) No 1272/2008, table 3.3.2, this substance should not be classified for this endpoint.