C4-C10 branched and linear hydrocarbons (light) – Naphtha

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

based on test type (migrated information)

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: see 'Remark'

Remarks:

Although the tests on the substance 'Light Alkylate Naphtha' indicated that the test material may not be a reproductive toxin (IUCLID data have not undergone any evaluation by the European Commision), the substance 'Naphtha (Fischer-Tropsch), light, C4-10, branched and linear' is stated to contain up to 6% n-hexane, which is classified in the EU as 'Toxic to Reproduction Category 3 (R62)' (concentrations >= 5%). Therefore 'Naphtha (Fischer-Tropsch), light, C4-10, branched and linear' should be also classified as 'Toxic to Reproduction Category 3 (R62)'.

Data source

Reference

Reference Type:

other: IUCLID Dataset

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)

Version / remarks:

(modified)

Deviations:

not specified

Principles of method if other than guideline:

no data

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

no data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

inhalation

Type of inhalation exposure (if applicable):

not specified

Vehicle:

not specified

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

- exposure: 6 hours per day
- duration: 8 weeks (males)
9 weeks (females)

Frequency of treatment:

7 days per week

Details on study schedule:

no data

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 5.1, 12.5, 24,7 mg/l
Basis:
no data

No. of animals per sex per dose:

no data

Control animals:

yes

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOAEL

Effect level:

24.7 mg/L air

Sex:

male/female

Basis for effect level:

other: no effect on parental food consumption, body weight or fertility up to and including 24.7 mg/l dose level

Results: F1 generation

Effect levels (F1)

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

24.7 mg/L air

Sex:

male/female

Basis for effect level:

other: no data

Overall reproductive toxicity

Reproductive effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

During the study of 'Light Alkylate Naphtha' (CAS No. 64741-66-8] no clinical signs indicative of systematic toxicity were observed. Inhalation exposure had no effect on parental food consumption, body weight or fertility, up to and including the 24.7 mg/l dose level. Evaluation of the parental reproductive organs (ovaries, testes and epididymides) did not reveal any weight or microscopic changes attributable to exposure. There were no differences in the mean number of corpora lutea, implantation sites and live pups per litter. Pups born from treated mothers showed comparable birth weights and weight gains. On postnatal day 4, all groups had a viability index >97%. Finally no gross anomalies were observed in pups.
Although the tests on 'Light Alkylate Naphtha' indicated that the test material may not be a reproductive toxin, the substance 'Naphtha (Fischer-Tropsch), light, C4-10, branched and linear' is stated to contain up to 6% n-hexane, which is classified in the EU as 'Toxic to Reproduction Category 3 (R62)' (concentrations >= 5%). Therefore 'Naphtha (Fischer-Tropsch), light, C4-10, branched and linear' should be also classified as 'Toxic to Reproduction Category 3 (R62)'.