Registration Dossier
Registration Dossier
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EC number: 938-148-1 | CAS number: 375-45-1
Endpoint summary
Administrative data
Description of key information
In vivo skin irritiation study (OECD TG 404, GLP) in rabbits: slight transient irritation
In vivo eye irritation study (OECD TG 405, GLP) in rabbits: slight transient irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 february 2003 to 20 June 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Remarks:
- mean score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Mean score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 1,2,3,4-tetrachloro-hexafluorobutane is a slight irritant following a single four-hour application to rabbit skin.
- Executive summary:
The purpose of this study was to assess the skin irritation potential of 1,2,3,4-tetrachloro-hexafluorobutane to rabbit, when administered by dermal application.
Three female rabbits each received a single four-hour application of 0.5 ml of 1,2,3,4-tetrachloro-hexafluorobutane to the shorn flank. The animals were assessed for up to 7 days for any signs of skin irritation.
There were no signs of irritation in one animal.
In two animals, very slight erythema and very slight oedema were seen approximately 1 hour after decontamination. Very slight erythema was also seen in one of these animals 2 days after application. Additional signs of irritation consisted of desquamation in one animal and erythema beyond the application area of the other animal. All signs of irritation had completely resolved within 7 days of application.
1,2,3,4-tetrachloro-hexafluorobutane is a slight irritant following a single four-hour application to rabbit skin.
Reference
There were no signs of ill-health in any animal during the study. The application site of one animal was stained by the test substance but this did not prevent the assessment of irritation.
There were no signs of irritation in one animal.
In two animals, very slight erythema and very slight oedema were seen approximately 1 hour after decontamination. very slight erythema was also seen in one of these animals 2 days after application. Additional signs of irritation consisted of desquamation in one animal and erythema beyond the application area of the other animal. All signs of irritation had completely resolved within 7 days of application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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 - 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
An in vivo study, performed in order to assess the skin irritation potential of 1,2,3,4-tetrachloro-hexafluorobutane to rabbit when administered by dermal application, is reported. The substance is a slight irritant following a single four-hour application to rabbit skin. Effects were fully cleared at the 24-hour observation.
An in vivo study, performed in order to assess the eye irritation potential of 1,2,3,4-tetrachloro-hexafluorobutane to rabbits, is reported.
The substance is practically non-irritant to the rabbit eye.
Justification for classification or non-classification
According to Regulation EC No. 1272/2008, the substance does not meet the classification criteria for human health for skin and eye irritation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
