Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

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:
ethyl (2Z)-4,4,4-trifluoro-3-(methylamino)but-2-enoate
EC Number:
801-277-8
Cas Number:
507448-65-9
Molecular formula:
C7H10F3NO2
IUPAC Name:
ethyl (2Z)-4,4,4-trifluoro-3-(methylamino)but-2-enoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Sciebtific des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: Approximately 8-12 weeks
- Weight at study initiation: 2500 - 2700 g
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14/hour
- Photoperiod: 12/12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml, one single dose to left eye of each animal. Right eye untreated an served as control.
- Concentration: As supplied

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Washed with distilled water for 1 minute after reading
- Time after start of exposure: 24 hors

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Other effects:
There was no mortality.
No remarkable clinical observations were recorded.
Body weights were not affected by treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:

According to the test results, CA 2455 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.

Executive summary:

 

An eye irritation/corrosion test was conducted with test article CA 2455 A (Intermediate CGA 276854) (batch LOT 3). The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours after treatment. 

Redness of the conjunctiva was observed in two animals at the 1-hour reading. All eye reactions were clear by day 1. There was no mortality. No remarkable clinical observations were recorded. Body weights were not affected by treatment. 

According to the test results, CA 2455 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.