Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

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

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:
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.
Body weight:
All animals gained weight as normal at the 3000 mg/kg dosage level. At the 2000 mg/kg dosage level, one female lost weight.
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

Categories Display