2-(2H-benzotriazol-2-yl)-p-cresol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Test performed according to proposed guideline, no details of test material purity. This substance differs in structure in a tertiary-butyl group in ortho position to the phenolic hydroxygroup and has a very similar toxicity profile. It is therefore considered adequate for read-across purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Proposed Guidelines of the US EPA 40CFR 163.81-5 'Primary dermal irritation study'

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

more stringent exposure conditions (24h onto abraded and non-abraded skin)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bumetrizole

EC Number:

223-445-4

EC Name:

Bumetrizole

Cas Number:

3896-11-5

Molecular formula:

C17 H18 Cl N3 O

IUPAC Name:

2-tert-butyl-6-(5-chloro-2H-benzotriazol-2-yl)-4-methylphenol

Details on test material:

- Name of test material (as cited in study report): TK 10048

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ivanovas, 7964 Kisslegg/Allgau, Germany; Madoerin AG, 4414 Fullinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): NAFAG No. 814 (Gossau AG) ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 deg C
- Humidity (%): 55+/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 h dark/ 10 h light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: both sides shaved, one side abraded

Vehicle:

other: propylene glycol:saline (70:30)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 % w/w

Duration of treatment / exposure:

24 h

Observation period:

7 days

Number of animals:

6 (3 per sex)

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm
- % coverage: no data
- Type of wrap if used: gauze patches covered with an impermeable material and fastened to the body with adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h


SCORING SYSTEM:
Skin reaction Value

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight
eschar formations (injuries in depth) 4

Edema formation:

No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by
definite raising) 2
Moderate edema (raised approximately 1 millimeter) 3
Severe edema (raised more than 1 millimeter
and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24h

Score:

1.16

Max. score:

2

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: At 48h, only one animal had an erythema. Values for non-abraded skin.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24h

Score:

0.16

Max. score:

1

Reversibility:

fully reversible within: 48h

Remarks on result:

other: values for non-abraded skin.

Other effects:

For abraded skin, almost identical scores were recorded.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU