4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 April 2001 to 15 April 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study was conducted in accordance with International guidelines and in accordance with GLP. All guideline validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol

Cas Number:

1478-61-1

Molecular formula:

C15H10F6O2

IUPAC Name:

4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol

Test material form:

solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, dark
- Stability under test conditions: Not reported
- Solubility and stability of the test substance in the solvent/vehicle: Not reported
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not reported

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test item was moistened with water (Milli-U) immediately before application.
- Preliminary purification step (if any): n/a
- Final dilution of a dissolved solid, stock liquid or gel: n/a
- Final preparation of a solid: n/a

FORM AS APPLIED IN THE TEST (if different from that of starting material) n/a

OTHER SPECIFICS: Test item was moistened with water (Mill-U) immediately before application.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 1.0 - 3.5 kg
- Housing: Individually housed in cages with perforated floors (Scanbur, Denmark - 53.5 x 63 x 38.5 cm)
- Diet (e.g. ad libitum): Standard laboratory diet (Charles River Breeding and Maintenance Diet for Rabbits, Altorim, Germany) supplied at 100 g / day.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: Minimum of 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 ºC
- Humidity (%): 30 - 70 %
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12:12 light:dark

IN-LIFE DATES: From: To: Not reported

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

test item moistened just prior to application with 1 mL Milli-U water to ensure contact with the skin

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (applied with 1 mL of Milli-U water)
- Concentration (if solution): n/a

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 mL
- Concentration (if solution): n/a
- Lot/batch no. (if required): n/a
- Purity: n/a

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): n/a
- Concentration (if solution): n/a

POSITIVE CONTROL
- Amount(s) applied (volume or weight): n/a
- Concentration (if solution): n/a

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 (males)

Details on study design:

TEST SITE
- Area of exposure: 2 x 3 cm
- % coverage: not reported
- Type of wrap if used: test item applied using metalline patch, which was subsequently held in place using micropore tape and a Coban elastic bandage. (Semi-occlusive).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, water used.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 h observations for irritation

SCORING SYSTEM:
- Method of calculation: erythema and oedema severity scored numerically on a scale of 0-4 (0: no erythema/ oedema, 1: very slight erythema/ oedema, 2: well defined erythema / slight oedema, 3: moderate erythema/ oedema, 4: severe erythema (beet redness, necrosis, deep injury)/ oedema)

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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

Irritant / corrosive response data:

No skin irritation was observed in any of the treated individuals. There was also no sign of skin corrosion, skin staining/ colouration, systemic toxicity or mortality.

Other effects:

- Other adverse local effects: none
- Other adverse systemic effects: none

Any other information on results incl. tables

Table 1:         Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0 / 0 / 0	0 / 0 / 0
24 h	0 / 0 / 0	0 / 0 / 0
48 h	0 / 0 / 0	0 / 0 / 0
72 h	0 / 0 / 0	0 / 0 / 0
Average 24h, 48h, 72h	0	0
Reversibility	n/a	n/a
Average time (unit) for reversion	n/a	n/a

n/a: not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item was considered to be non-irritant and therefore cannot be classified as irritating to skin.

Executive summary:

In a primary dermal irritation study (OECD 404), young adult New Zealand white rabbits (3 males) were dermally exposed to 0.5 g of test item in 1 mL of water for 4 hours to a 2 x 3 cm area.  The test item was applied on to the clipped skin under semi-occlusive dressing. Animals then were observed for 3 days.  Irritation, including erythema and oedema formation, was scored numerically on a scale of 0-4 based on severity.

 

No erythema or oedema were observed in any of the treated individuals. In addition there were also no local or systemic effects observed and no mortality occured.

 

In this study, test item is not a dermal irritant.