2,2''-dihydroxy-4,4''-(2-hydroxy-propane-1,3-diyldioxy)dibenzophenone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-08-22 to 1996-08-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 July 1992

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:

-

EC Number:

424-210-0

EC Name:

-

Cas Number:

23911-85-5

Molecular formula:

C29 H24 O7

IUPAC Name:

2-benzoyl-5-[3-(4-benzoyl-3-hydroxyphenoxy)-2-hydroxypropoxy]phenol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12 - 16 weeks old
- Weight at study initiation: 2.38 to 2.45 kg
- Housing: metal cages
- Diet (ad libitum): STANRAB SQC Rabbit Díet, Special Diets Services Ltd, Witham, Essex, UK
- Water (ad libitum): yes
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 22
- Humidity (%): 65 - 74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not specified

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

1 h, 24 h, 48 h and 72 h upon removal of the patches

Number of animals:

3 animals (3 male)

Details on study design:

TEST SITE
- Area of exposure: dorsal flank area
- % coverage: not specified
- Type of wrap used: gauze patch secured in position with a strip of surgical adhesive tape (to prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset)

REMOVAL OF TEST SUBSTANCE
- Washing: residual test material was removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
24, 48 and 72 hours (after removal of the patches)

SCORING SYSTEM:
according to the scale from Draize J H, (1977) "Dermal and Eye Toxicity Tests" ln: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.31.

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

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at two treated skin sites one hour after patch removal.
No other evidence of erythema was noted. No evidence of oedema was noted during the study.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material produced a 24/48/72 h mean erythema and edema score of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.

Executive summary:

A study was performed to assess the irritancy potential of the test material FADEX He 1819 PK to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal lrritation/Corrosion" (adopted 17 July 1992) and Method 84 of Commission Directive 92169/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites one hour after patch removal. The test material produced a 24/48/72 h mean erythema and edema score of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.