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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The method used followed that described in the OECD Guidelines for Tesing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' and Method B5 of 67/548/EEC.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-oxo-4-azaandrost-5-ene-17β-carboxylic acid
EC Number:
407-830-6
EC Name:
3-oxo-4-azaandrost-5-ene-17β-carboxylic acid
Cas Number:
103335-54-2
Molecular formula:
Hill formula: C19H27NO3 CAS formula: C19H27NO3
IUPAC Name:
4a,6a-dimethyl-2-oxo-1H,2H,3H,4H,4aH,4bH,5H,6H,6aH,7H,8H,9H,9aH,9bH,10H-indeno[5,4-f]quinoline-7-carboxylic acid
Details on test material:
- Name of test material (as cited in study report): GR91287X
- Molecular formula (if other than submission substance): C19-H27-N-O3
- Molecular weight (if other than submission substance): 317.43
- Analytical purity: >95%
- Lot/batch No.: CO-0099
- Storage condition of test material: room temp in dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd
- Age at study initiation: 12- 16 weeks
- Weight at study initiation: 2.34 - 2.98 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 58- 74
- Air changes (per hr): ca 15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: To: 1995-10-16 - 1995-10-21

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10mg 1st rabbit, 0.1ml (ca. 58mg) rabbit 2, 3 and 4
- Concentration (if solution): 100 %
Duration of treatment / exposure:
one dose as above.
Observation period (in vivo):
at dose, 1, 3, 6, 24, 48 and 72hrs.
Number of animals or in vitro replicates:
4 females
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV light and fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(Female) 48
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects noted.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(Female) 26
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects noted.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(Female) 37
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects noted.
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(Female) 48
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects noted.
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(Female) 26
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects noted.
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(Female) 37
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: No effects noted.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
(Female) 48
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: No effects noted.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
(Female) 26
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
3
Reversibility:
other: No effects noted.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
(Female) 37
Time point:
other: mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(Female) 48
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects noted.
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(Female) 26
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects noted.
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(Female) 37
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: No effects noted.
Irritant / corrosive response data:
Non-irritant or corrosive

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
non-irritant or corrosive.
Executive summary:

GR92187X did not meet the criteria necessary for classification as an irritant to the eye according to EC labelling regulations. No symbol and risk phrase are required.