Phenol, reaction products with 1-halo-4-phenoxybenzene and 1,1’–oxybis[4-halobenzene], halogenated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5th April 2011 to 8th April 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A GLP compliant study performed in line with appropriate guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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

Details on test material:

- Physical state: off-white solid
- Storage condition of test material: room temperature in the dark
- pH: 5 (immediately); 4.0 (after 10 minutes); 3.9 (after 20 minutes)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd, Loughborough, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.02-2.73 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): 2930 Teklad Global Rabbit Diet ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23ºC
- Humidity (%): 30-70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g of test substance as supplied moistened sufficiently with 0.5 mL distilled water

Duration of treatment / exposure:

Four hours

Observation period:

72 hours

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: 25 cm x 2.5 cm cotton gauze patch
- Type of wrap if used: surgical adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: four hours

SCORING SYSTEM:
Erythema and Eschar formation
No erythema 0
Very slight erythema 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema to eschar formation 4

Oedema formation
No oedema 0
Very slight oedema 1
Slight oedema 2
Moderate oedema 3
Severe oedema 4

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

8

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

All animals showed expected bodyweight gain during the study.

Any other information on results incl. tables

Table 1: Individual skin reactions

Skin Reaction	Observation Time (Following Patch Removal)	Individual Scores - Rabbit Number and Sex			Total
		70280 Male	70281 Male	70282 Male
Erythema/Eschar Formation	Immediately	0	0	0	(0)
	1 hour	0	0	0	(0)
	24 hours	0	0	0	0
	48 hours	0	0	0	(0)
	72 hours	0	0	0	0
Oedema Formation	Immediately	0	0	0	(0)
	1 hour	0	0	0	(0)
	24 hours	0	0	0	0
	48 hours	0	0	0	(0)
	72 hours	0	0	0	0
Sum of 24 and 72 Hour Readings: (S):				0
Primary Irritation Index (S/6):				0/6 = 0
Classification:				NON IRRITANT

() = Values not included for calculating the primary irritation index.

Table 2: Individual bodyweights and bodyweight changes

Rabbit number and sex	Individual bodyweight (kg)		Bodyweight change (kg)
	Day 0	Day 3
70280 male	2.13	2.22	0.09
70281 male	2.02	2.11	0.09
70282 male	2.73	2.83	0.10

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, the test substance produced a primary irritation index score of 0.0 and is classified as a non-irritant to rabbit skin according to the Draize classification scheme.

Executive summary:

In a GLP compliant skin irritation study conducted in line with OECD Guideline 404 and EU Method B.4, the skin irritation of the test substance was investigated. The substance produced a Primary Irritation Index score of 0.0 and was classified as a non-irritant according to the Draize classification scheme.