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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(3R)-3-amino-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoic acid
EC Number:
923-144-4
Cas Number:
1182722-58-2
Molecular formula:
C15 H18 N2 O2
IUPAC Name:
3-[(3R)-3-amino-2,3,4,9-tetrahydro-1H-carbazol-9-yl]propanoic acid

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: 3 males
- Source: Chr. FRED LEUSCHNER & CO, D-24601 Löhndorf/Post, Wankendorf
- Age at study initiation: approx. 3 months
- Weight at study initiation: 1.9-2.1 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the left eye, which remained untreated, served as control
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single instillation of the test substance into the conjunctival sac; no rinsing of the eye at any time; 24 hours after administration the eyes were treated additionally with fluorescein and examined.
Observation period (in vivo):
1, 24, 48 and 72 hours after instillation
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
24 hrs fluorescein test: no pathological findings.
Other effects:
No systemic intolerance reactions were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

In an acute eye irritation study according to OECD TG 405 100 mg of test substance per animal was applied into the conjunctival sac of the right eye of 3 male rabbits. No rabbit showed any substance-related changes at the examination time-points 1, 24, 48 and 72 hours after the administration. The cornea, iris and conjunctivae were not affected by instillation of the test compound. No systemic intolerance reactions were observed.