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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study based on early national standard, well documented, acceptable for assessment due to absence of effects (despite 24h exposure)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: CFR/USA, Title 16, Section 1500.41
Principles of method if other than guideline:
according to the Consumer Product Safety Commission/USA: 24 h exposure

GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Produkt-Nr. 111.184 (= 3,5-dimethyl phenol)
- Molecular formula (if other than submission substance): C8H10O
- Substance type: organic
- Physical state: solid
- Analytical purity: specified as "pure"
- Impurities (identity and concentrations): no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: J. Scheele, Werl/Germany
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: mesh metal cage
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Air-conditioned room
- Temperature (°C): 22 +-1 °C
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved intact and abraded
Vehicle:
other: Polyethylene glycol (PEG) 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg mixed with 0.5 mL PEG

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: gauze/mull soaked with the test suspension, fixed with adhesive bandage ("Elastoplast")

SCORING SYSTEM: numerical scoring system of effects according to Draize (erythema, oedema, other lesions such as necrosis)
(ETAD recommendation)

- EVALUATION: Reading after 24 and 72 h and
calculation of a "Primary Irritation Index" = Sum of effects (erythema and oedema) at both time points for each animal
divided by 24 (4 effects values each, 6 animals).

The ranking system of the "Primary Irritation Index" was as follows
(based on ETAD recommendation):
0.0 - 0.5 not irritating
0.6 - 3.0 slightly irritating
3.1 - 5.0 moderately irritating
5.1 - 8.0 severely irritating

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
(6 animals)
Time point:
other: 24 and 72 h
Score:
0.25
Max. score:
8
Irritant / corrosive response data:
Slight oedema in 3/6 animals (24 h after application), no effects after 72 h, no difference between intact and scarified skin

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU