Registration Dossier

Administrative data

Description of key information

Two in vivo studies performed in order to assess the acute dermal and eye irritation potential of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane are reported.
1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is not irritant both to rabbit skin and rabbit eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 1987 to 13 August 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (2 males + 1 female)
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
(including at 1h time point)
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
(including at 1h time point)
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
Remarks:
(including at 1h time point)
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
Remarks:
(including at 1h time point)
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
Remarks:
(including at 1h time point)
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
Remarks:
(including at 1h time point)

In all animals, at all time points, no dermal irritation was noted.

Interpretation of results:
GHS criteria not met
Remarks:
CLP-Regulation (EC) No 1272/2008
Conclusions:
No dermal irritation was noted.
It was concluded that 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is not irritant to rabbit skin.
Executive summary:

The IRI project No.238237, includes an acute oral toxicity test, an eye irritation test and a dermal irritation test.

In the dermal irritation test, three rabbits were treated with 0.5 ml of 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane in a

4 -hour semi-occluded exposure. No irritation was noted following the exposure.

It is concluded that 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is not irritant to rabbit skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 July 1987 to 13 August 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
one single instillation (0.1 ml)
Observation period (in vivo):
1, 24, 48, 72 hours.
Number of animals or in vitro replicates:
3 (2 males + 1 female)
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
other: Conjunctival Discharge
Basis:
animal: 1,2,3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation

In all animals, at all time points, no irritant responses were noted.

Interpretation of results:
GHS criteria not met
Conclusions:
No irritant responses were noted.
It was concluded that 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is practically non-irritant to rabbit eyes
Executive summary:

The IRI project No.238237, includes an acute oral toxicity test, an eye irritation test and a dermal irritation test.

In the acute eye irritation test, three rabbits were treated with a single instillation of 0.1 ml of the test item.

The eyes were examined for irritation, using standard illumination, at 1, 24, 48 and 72 hours after instillation, using scoring system.

No corneal, iridial or conjunctival responses were noted.

It is concluded that 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is non-irritant to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Under the acute dermal irritation test in rabbit, no irritation was noted following a 4 -hours semi-occlusive exposure.

It is concluded that 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is not irritant to rabbit skin.

Under the acute eye irritation test in rabbits no corneal, iridial or conjunctival responses were noted.

It is concluded that 1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane is non-irritant to rabbit eyes.

Justification for classification or non-classification

1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane does not meet the classification criteria of Regulation EC No.1272/2008 both for skin and eye irritation.