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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

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:
1-bromobutane
EC Number:
203-691-9
EC Name:
1-bromobutane
Cas Number:
109-65-9
Molecular formula:
C4H9Br
IUPAC Name:
1-bromobutane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: A local supplier to the testing laboratory
- Age at study initiation: 20-20 weeks old
- Weight at study initiation: 2- 3.5 kg
- Housing: in suspended metal cages
- Diet :Certified rabbit diet code 5322
- Water: Free access to mains drinking water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
Room temperature: 17-23oc
Relative humidity: 30-70%
air exchange rate: 15 changes per hour, 12 hr light and 12 hr darkness

IN-LIFE DATES: NDA

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye served as negative control
Amount / concentration applied:
0.1 ml of test material
Duration of treatment / exposure:
The lids were gently held together for 1 second before releasing the rabbit. The eyes were not washed following treatment.
Observation period (in vivo):
The eyes were examined and grade of ocular reaction recorded at 1, 24, 48, 72 hrs with the aid of a standard ophthalmoscope to observe any corneal lesions and the degree of irritation recorded.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
- Time after start of exposure: N/A

SCORING SYSTEM:
Grading of eye irritation was done using the numerical data obtained a system described by Kay J H and Calandra J C, J. Soc. Cosmet. Chem., 1962 13 281-289

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
10
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48 and 72 hrs
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
6
Max. score:
10
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48 and 72 hrs
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
4
Max. score:
10
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48 and 72 hrs
Score:
0
Max. score:
10
Irritant / corrosive response data:
The test material produced a maximum group mean score of 9.3 and was classified as a MINIMAL IRRITANT to the rabbit eye according to a modified
Kay and Calandra classification system.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008.
Executive summary:

The test material produced a maximum group mean score of 9.3 and was classified as a MINIMAL IRRITANT to the rabbit eye according to a modified Kay and Calandra classification system.

The test material did not meet the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008.