Stoddard solvent

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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

Justification for type of information:

Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.
The rabbits were observed for a period of 14 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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:

C9-C12 Mixed aliphatics and aromatics (8052-41-3) Boiling Point Range 160-199 °C

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

5 male/female rabbits
TEST ANIMALS- Source: Alpine Laboratory Rabbits- Age at study initiation: Young adult
- Weight at study initiation: 1.9-2.40 kg at time of dosing
- Housing: Individually
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): ad libitum- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 74 °F
- Humidity (%): 31 - 70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12 hour, light/dark cycle

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.

Duration of exposure:

24 hours

Doses:

2000 mg/kg and 3000 mg/kg

No. of animals per sex per dose:

4 male/female rabbits

Control animals:

yes

Details on study design:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.
All animals exhibited loss of appetite and hypoactivity on the first day after exposure. At the lowest dose level thickening and redness of the skin developed. One low-dose female with skin abrasion died three days after exposure

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no signs of systemic or organ toxicity were noted.

Mortality:

All ten animals survived to termination of the study.

Clinical signs:

other: Dermal irritation that lasted till termination of the study.

Gross pathology:

No visible lesions, with the exception of the dermal effects.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The LD50 for Stoddard solvent is >3000 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

Four New Zealand White rabbits of each sex were exposed for 24 h with a bandage containing doses of 2.0 or 3.0 g/kg body weight of white spirit (Stoddard solvent) (14.5% aromatics). The exposed area, which measured about 10% of the body surface, was shaved before exposure and the skin of two animals in each dose group was abraded.

All animals exhibited loss of appetite and hypoactivity on the first day after exposure. At the lowest dose level thickening and redness of the skin developed. One low-dose female with skin abrasion died three days after exposure