Tar acids, 3,5-xylenol fraction

Skin irritation / corrosion

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 for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

3,5-xylenol

EC Number:

203-606-5

EC Name:

3,5-xylenol

Cas Number:

108-68-9

Molecular formula:

C8H10O

IUPAC Name:

3,5-dimethylphenol

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 or test system 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