4-chloro-α,α,α-trifluorotoluene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

Patch test

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-chloro-α,α,α-trifluorotoluene

EC Number:

202-681-1

EC Name:

4-chloro-α,α,α-trifluorotoluene

Cas Number:

98-56-6

Molecular formula:

C7H4ClF3

IUPAC Name:

1-chloro-4-(trifluoromethyl)benzene

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Parachlorbenzotrifluorid
- Physical state: colourless liquid

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1,5 -2,0 kg
- Housing: individually caged
- Diet: ERKA 8300 ad libitum
- Water: ad libitum


IN-LIFE DATES: From: 3 February To: 7 February

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: sesame oil

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted
- Amount(s) applied (volume or weight with unit): 10% diluted

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: right flank for undiluted product application, left flank for diluted product application
-Area of coverage: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze wrapped by PVC sheet and fixed by adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: Federal Register 38, N. 187 (27/09/1973), cap. 1500.41

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal: 12

Time point:

24/48/72 h

Score:

0.66

Reversibility:

not fully reversible within: 96 h

Results 2

Irritation parameter:

edema score

Basis:

animal: 5

Time point:

24/48/72 h

Score:

1.33

Reversibility:

not fully reversible within: 96 h

Results 3

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Reversibility:

not fully reversible within: 96 h

Results 4

Irritation parameter:

edema score

Basis:

animal: 3

Time point:

24/48/72 h

Score:

2.33

Reversibility:

not fully reversible within: 96 h

Results 5

Irritation parameter:

edema score

Basis:

animal: 2

Time point:

24/48/72 h

Score:

2.33

Reversibility:

not fully reversible within: 96 h

Results 6

Irritation parameter:

edema score

Basis:

animal: 1

Time point:

24/48/72 h

Score:

1

Reversibility:

not fully reversible within: 96 h

Results 7

Irritation parameter:

erythema score

Basis:

animal: 12

Time point:

24/48/72 h

Score:

0

Results 8

Irritation parameter:

erythema score

Basis:

animal: 2

Time point:

24/48/72 h

Score:

1

Reversibility:

not fully reversible within: 96 h

Results 9

Irritation parameter:

erythema score

Basis:

animal: 1, 3, 5

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible

Irritant / corrosive response data:

Non irritant and non corrosive

Any other information on results incl. tables

Application on right flank (undiluted product)

Animal N.	Skin Reaction	24 hs after Application		48 hs after Application		72 hs after Application		96 hs after Application		Sum
		Intact	Scarified	Intact	Scarified	Intact	Scarified	Intact	Scarified	24+72  (1+5+6)
1	Erythema  Oedema	1 2	1 1	0 1	1 0	0 0	0 0			5
2	Erythema  Oedema	1 4	1 3	1 2	1 1	1 1	1 0			12
3	Erythema  Oedema	1 3	1 3	0 2	1 2	0 2	0 2			12
4	Erythema  Oedema	0 3	0 1	0 2	0 1	0 1	0 1			6
5	Erythema  Oedema	1 2	1 1	0 1	1 0	0 1	1 0			7
12	Erythema  Oedema	0 1	0 1	0 1	0 1	0 0	0 1			3

Application on left flank (diluted product)

Animal N.	Skin Reaction	24 hs after Application		48 hs after Application		72 hs after Application		96 hs after Application		Sum
		Intact	Scarified	Intact	Scarified	Intact	Scarified	Intact	Scarified	24+72  (1+5+6)
1	Erythema  Oedema	0 0	1 0	0 0	0 0	0 0	0 0			1
2	Erythema  Oedema	0 0	0 0	0 0	0 0	0 0	0 0			0
3	Erythema  Oedema	0 1	1 1	0 0	0 1	0 0	1 0			4
4	Erythema  Oedema	0 1	0 0	0 1	0 0	0 0	0 0			1
5	Erythema  Oedema	0 0	1 0	0 0	0 0	0 0	1 0			2
12	Erythema  Oedema	0 0	0 1	0 0	0 0	0 0	0 0			1

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

The test item results non irritating and non corrosive to skin.

Executive summary:

The test item was applied to the skin of the flank of 6 rabbits, through occlusive coverage. The right flank was treated with the undiluted product, while the left flank was treated with the 10% dilution of the product in sesame oil. The exposure time was 24 hours; the observation period was up to 72 hs. The irritation index was calculated based on erythema and oedema scores after 24 and 72 hours and it was found to be 1.9 for the undiluted product and 0.4 for the dilution. It is concluded that the test item is not irritating nor corrosive to skin.