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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:
22 January 2003 to 19 June 2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(1992)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluorobutane
EC Number:
938-148-1
Cas Number:
375-45-1
Molecular formula:
C4Cl4F6
IUPAC Name:
1,2,3,4-tetrachloro-1,1,2,3,4,4-hexafluorobutane
Details on test material:
- Name of test material (as cited in study report): A1112 Dimer
- Substance type: pure substance
- Physical state: liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 99% pure substance
- Isomers composition: not applicable
- Purity test date: not reported
- Lot/batch No.: DAD 619
- Expiration date of the lot/batch: 2005

- Storage condition of test material: ambient temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, UK
- Age at study initiation: no data (young adults), 3 females
- Weight at study initiation: 2236 - 3022 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): minimum 15 ACH
- Photoperiod (hrs dark / hrs light): 12 h light, 12 hrs dark

IN-LIFE DATES: From: 29-JAN-2003 To: 14-FEB-2003

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
The test substance (0.1 ml) was instillated once, on day 1.
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hour
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hour
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1.2 hour
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1.2 hour
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
3 animals
Time point:
other: 1 hour
Score:
1.3
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
3 animals
Time point:
24 h
Score:
0.7
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
3 animals
Time point:
48 h
Score:
0
Max. score:
110
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
3 animals
Time point:
72 h
Score:
0
Max. score:
110

Any other information on results incl. tables

There were no signs of ill-health in any naimal during the study. Instillation into the eye caused practically no initial pain (class 1 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in two animals for up to 1 day and slight chemosis in one animal approximately 1 hour after instillation only. There were no additional signs of irritation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
1,2,3,4-tetrachloro-hexafluorobutane is not an eye irritant.
Executive summary:

The purpose of the study was to assess the eye irritation potential of 1,2,3,4-tetrachloro-hexafluorobutanet o rabbits.


The study was conducted in accordance with guidelines OECD 405 (1987), EU method B.5 (1992) and EPA OPPTS 870.2400 (1998).


A volume of 0.1 ml of 1,2,3,4-tetrachloro-hexafluorobutane was instilled into one eye of each of three rabbits and an assessment of initial pain was made.


The eyes were examined for 3 days, to assess the grade of ocular reaction.


There were no signs of ill-health in any animal during the study. Instillation into the eye caused practically no initial pain (class 1 on a 0 -5 scale). There were no corneal or iridial effects. Conjunctival effects consisted of slight redness in two animals clearing within 24 hours and slight chemosis in one animal approximately 1 hour after instillation only. There were no additional signs of irritation.


1,2,3,4-tetrachloro-hexafluorobutane is not classified as an eye irritant according to GHS criteria.