Stoddard solvent

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Stoddard solvent

EC Number:

232-489-3

EC Name:

Stoddard solvent

Cas Number:

8052-41-3

Molecular formula:

C10H22

IUPAC Name:

stoddard solvent

Test material form:

liquid

Specific details on test material used for the study:

Stoddard solvent (14.5% aromatics) CAS (8052-41-3) Boiling Point Range 160-199 °C

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.5 kg
- Housing: individual cages, identified with ear tags
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum, 15 g/day
- Water (e.g. ad libitum): deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

24 hrs

Observation period:

Observations were made at 24 and 72 hrs after end of exposure.

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: 2.5 x 2.5 cm area
- Type of wrap if used: cellulose bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

4.5

Reversibility:

not specified

Remarks on result:

other: moderate to severe irritant; edema after 24 hrs

Irritant / corrosive response data:

The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

Other effects:

Microscopic examination showed hardening of the skin, hyperkeratosis, and misalignment with nearby skin.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test substance is irritating to skin according to the DSD and CLP.
The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated

Executive summary:

In a test for primary dermal irritation, 0.5 ml of Stoddard solvent (14.5% aromatics) was applied to the shaved (abraded and nonabraded) skin of six male New Zealand White rabbits. The exposed area was covered with an occlusive dressing for 24 h. The exposure caused moderate to severe erythema and oedema according to the Draize test after 24 h of skin contact. After 72 h, a primary dermal irritation index of 4.5 was calculated