Naphtha (petroleum), heavy catalytic cracked

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

64741-55-5

Cas Number:

64741-55-5

IUPAC Name:

64741-55-5

Constituent 2

Reference substance name:

Light catalytically cracked naphtha

IUPAC Name:

Light catalytically cracked naphtha

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

Density: 0.75 g/ml

Test animals

Species:

rat

Strain:

Sprague-Dawley

Administration / exposure

Route of administration:

dermal

Duration of treatment / exposure:

gestation days 0 to 19

Frequency of treatment:

once daily

Duration of test:

19 days

Doses / concentrations

Remarks:

Doses / Concentrations:
Dose levels of 30, 125 and 500 mg/kg/day
Basis:

Control animals:

yes, concurrent vehicle

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:

Maternal toxic effects:no effects

Details on maternal toxic effects:
Daily application of test material to the skin of pregnant rats during gestation produced dermal irritation at the application sites at all dose levels. The irritation ranged from slight to moderate. Maternal parameters (food consumption, body weight gain, serum chemistry) were monitored throughout gestation and showed no adverse trends. No adverse effects were observed on reproductive parameters (number of implants, resorptions, or viable fetuses)

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

500 mg/kg bw/day

Basis for effect level:

other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
No adverse effects were observed on fetal parameters (body weight or crown:rump length). No evidence of teratogenicity was observed in fetuses from pregnant dams exposed to the test material. It was concluded that dermal administration of light catalytically cracked naphtha does not adversely affect parameters of reproductive performance during gestation, nor does it adversely affect in utero survival and development of concepti.

Effect levels (fetuses)

Dose descriptor:

NOAEL

Effect level:

500 mg/kg bw/day

Basis for effect level:

other: teratogenicity

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on the study results, the maternal NOAEL and the teratogenicity NOAEL were greater than 500mg/kg. These findings do not warrant the classification of light catalytically cracked naphtha as a developmental hazard under 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:

Light catalytically cracked naphtha was administered once daily to pregnant rats on gestation days 0-19 via dermal application at doses of 30, 125, and 500 mg/kg to assess for developmental toxicity. Maternal parameters (food consumption, body weight gain, serum chemistry) were monitored throughout gestation and were not adversely affected by treatment. No adverse effects were observed on eproductive parameters (number of implants, resporptions, or viable fetuses) or on fetal parameters (body weight or crown:rump length). No evidence of teratogenicity was observed in fetues from pregant dams exposed to the test material. Based on the study results, the maternal NOAEL and the teratogenicity NOAEL were greater than 500mg/kg. These findings do not warrant the classification of light catalytically cracked naphtha as a developmental hazard under 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.