Mixed LOF

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented study report similar or equivalent to OECD TG 402 performed under GLP conditions on an analogue substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), light catalytic cracked

EC Number:

265-056-2

EC Name:

Naphtha (petroleum), light catalytic cracked

Cas Number:

64741-55-5

IUPAC Name:

Naphtha (petroleum), light catalytic cracked

Constituent 2

Reference substance name:

light catalytic cracked naphtha

IUPAC Name:

light catalytic cracked naphtha

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg and 3000 mg/kg

No. of animals per sex per dose:

4 males and 4 females per dose

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 000 mg/kg bw

Mortality:

No deaths resulted.

Clinical signs:

other: Dermal irritation ranged from slight to severe, and from slight to marked for atonia, desquamation and fissuring. Blanching and eschar formation were noted at the test sites for both doses. Subcutaneous haemorrhage was only found at the 3000 mg/kg dose.

Gross pathology:

At necropsy, thickened and crusted skin at the test site was noted.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 for light catalytic cracked naphtha (API 83-20) is >3000 mg/kg. This finding does not warrant classification of the test material 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:

The acute toxicity of light catalytic cracked naphtha (API 83-20) was evaluated in rabbits via occlusive dermal application at 2000 mg/kg and 3000 mg/kg body weight. Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the following14 days. All animals at the higher dose level survived to termination of the study period; two animals died at the 2000 mg/kg dosage level. Dermal irritation ranged from slight to severe, and from slight to marked for atonia, desquamation and fissuring. Blanching and eschar formation were noted at the test sites for both doses. Subcutaneous haemorrhage was only found at the 3000 mg/kg dose. At necropsy, thickened and crusted skin at the test site was noted.The LD50 for light catalytic cracked naphtha (API 83-20) is >3000 mg/kg. This finding does not warrant classification of the test material 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