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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented stud report which meets basic scientific principles; pre-GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
2 animals, treatment time: 1, 5, 15 min, 20 hours; onservation after 24 hours and 8 days
Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Remarks:
pre-GLP study

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,3,6-Trimethyl-Phenol (TMP)
Analytical purity: 99%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
light/dark rhythm: 12/12 hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
water
Controls:
other: untreated sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): 50% aqueous suspension
No further data
Duration of treatment / exposure:
1 minute, 5 minutes, 15 minutes, 20 hours (dorsal skin)
20 hours (inner auricle)
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: back and ear
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM:
BASF scores, convertible into Draize scores, readings at 24 hours and 8 days after beginning of application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0-8 days
Score:
>= 1 - <= 3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: necrosis
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0-8 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
see table

Any other information on results incl. tables

Draize scores (erythema and edema) and findings:

Site

Exposure

 time

24-hour reading

8-day reading

Animal no. 1

Animal no. 2

Animal no. 1

Animal no. 2

Back

1 min

Erythema: 2

No finding

No finding

No finding

5 min

Erythema: 2

No finding

No finding

No finding

15 min

Erythema: 3

Erythema: 1

Slight desquamation

No finding

20 h

Centre:

whitish-anemic

Surrounding area:

Erythema: 2

Erythema: 2

Necrotic focus (area ca. 1 cm²)

Superficial necrosis

Erythema: 2

Superficial necrosis

Ear

20 h

Erythema: 2

Spotted anemic

Erythema: 2

Superficial necrosis

Encrustation

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

A 50% aqueous preparation applied for up to 20 hours under semiocclusive conditions was irritating to the skin of rabbits.