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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Proposed Guidelines of the US EPA 40CFR 163.81-5 'Primary dermal irritation study'
Qualifier:
equivalent or similar to
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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.
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