2,2-dichloro-1,1,1-trifluoroethane

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study scientifically acceptable. No GLP compliant, not in line with OECD TG

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Appears to be similar to OECD Guidelines for skin sensitization (406), however, limited methodology was provided to completely assess similarity to OECD guidelines. No information was provided on positive control to assess validity of study.

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

At the time of testing (1975), the LLNA method was not yet adopted as OECD Guideline and not yet identified as the standard information requirement. For this reason the use of the guinea pig maximisation test (GPMT) was considered to be acceptable.

Test material

Test material information

Constituent 1

Reference substance name:

2,2-dichloro-1,1,1-trifluoroethane

EC Number:

206-190-3

EC Name:

2,2-dichloro-1,1,1-trifluoroethane

Cas Number:

306-83-2

Molecular formula:

C2HCl2F3

IUPAC Name:

2,2-dichloro-1,1,1-trifluoroethane

Constituent 2

Reference substance name:

Ethane, 2,2-dichloro-1,1,1-trifluoro- -

IUPAC Name:

Ethane, 2,2-dichloro-1,1,1-trifluoro- -

Details on test material:

- Name of test material (as cited in study report): Ethane, 1,1-Dichloro-2,2,2-Trifluoro (FC-123)
- Molecular formula (if other than submission substance): CHCL2CF3
- Molecular weight (if other than submission substance): 153 g/mole
- Physical state: liquid
- Purity: 99.9405% FC-123

In vivo test system

Test animals

Species:

guinea pig

Strain:

other: Species not specified, male albino

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
Initial average body weight = 580 g
Final average body weight = 779 g
Control animals average body weight = 740 g

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: Intradermal injection included dimethyl phthalate and the challange agent included propylene glycol

Induction 2

Concentration / amount:

Intradermal injections consisted of 1% solution (vol./vol.) of test material in dimethyl phthalate (DMP). The challenge solution was 50% and a 10% solution (wt./vol.) of test material in propylene glycol.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: Intradermal injection included dimethyl phthalate and the challange agent included propylene glycol

Challenge 2

Concentration / amount:

Intradermal injections consisted of 1% solution (vol./vol.) of test material in dimethyl phthalate (DMP). The challenge solution was 50% and a 10% solution (wt./vol.) of test material in propylene glycol.

No. of animals per dose:

10 animals per dose

Details on study design:

MAIN STUDY

A. INDUCTION EXPOSURE
- No. of exposures: 4 sacral intradermal injections
- Exposure period: 3-week period
- Test groups: 10 animals per dose
- Control group: 10 animals
- Frequency of applications: One injection per week
- Concentrations: 0.1 mL of a 1% solution (vol/vol) of test material in dimethyl phthalate (DMP)
- Rest period prior to challenge: Two weeks

B. CHALLENGE EXPOSURE
- Test groups: 10 animals per dose group
- Control group: 10 animals per dose group
- Site: Shoulder
- Concentrations: 50% and 10% - 1 drop (~0.05 mL) each of a 50% and a 10% solution (wt/vol) of test material in propylene glycol was lightly rubbed on the shaved intact shoulder skin.
- Evaluation (hour after challenge): 24 hours and 48 hours

Challenge controls:

10 previously unexposed guinea pigs received similar applications at the time of challenge to provide a direct comparison of the challenge reactions on skin of similar age.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

50%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10%

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, no sensitization was observed at challenge in a guinea pig skin sensitization test with 1,1,-dichloro-2,2,2-trifluoro-ethane in a 50% and a 10% solution in propylene glycol.