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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-chloro-7H-pyrrolo[2,3-d]pyrimidine
EC Number:
628-079-2
Cas Number:
3680-69-1
Molecular formula:
C6H4ClN3
IUPAC Name:
4-chloro-7H-pyrrolo[2,3-d]pyrimidine
Test material form:
solid: particulate/powder

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.