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Toxicological information

Toxicity to reproduction

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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: According to or similar to guideline study OECD 415/GLP: data available in public domain, not all raw data included in publication.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
HPV Lubricating Oil Basestocks Test Plan and Robust Summary
Author:
Petroleum HPV test group
Year:
2002
Reference Type:
publication
Title:
Assessment of the potential reproductive and subchronic toxicity of EDS coal liquids in Sprague-Dawley rats.
Author:
Mckee, RH
Year:
1987
Bibliographic source:
In Toxicology, vol. 46 pp 267-280

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
White mineral oil (petroleum)
EC Number:
232-455-8
EC Name:
White mineral oil (petroleum)
Cas Number:
8042-47-5
IUPAC Name:
8042-47-5
Constituent 2
Reference substance name:
a food/ drug grade severely refined base oil, referred to in the publication as 8012-95-1, however this is a generic reference used at the time to specify what is now referred to as 8042-47-5.
IUPAC Name:
a food/ drug grade severely refined base oil, referred to in the publication as 8012-95-1, however this is a generic reference used at the time to specify what is now referred to as 8042-47-5.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: white oil
Details on exposure:
72 male/female Sprague-Dawley rats were given white oil at a dose of 5ml/kg, 5 days/week for 13 weeks. After this time each of the males was housed with 2 females for 10 consecutive nights, or until mating was confirmed by copulatory plug. The mated females were maintained without further dosing through gestation and lactation to post-partum day 21.
Doses / concentrations
Remarks:
Doses / Concentrations:
5ml/kg
Basis:
nominal conc.

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
> 4 350 mg/kg bw/day
Sex:
male/female

Results: F1 generation

General toxicity (F1)

Clinical signs:
no effects observed
Mortality / viability:
no mortality observed
Body weight and weight changes:
no effects observed
Sexual maturation:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings:
no effects observed

Details on results (F1)

In one white oil group, 3 malformed pups were found in 2 litters. Two of the malformed pups had syndactyly and renal agenesis and one of these also exhibited agnathia. The third pup had a small eye. In the other white oil group, four malformed pups were found in 4 litters. Two of the pups had tail abnormalities, one had a depression in the sternum and the fourth had a short snout. The authors comment that a similar spectrum of malformations in Sprague-Dawley rats from the same supplier has been reported elsewhere. The authors also comment that this spectrum of malformations can occur spontaneously in the Sprague-Dawley rat and are not regarded as treatment-related.

Effect levels (F1)

Dose descriptor:
NOAEL
Generation:
F1
Effect level:
> 4 350 mg/kg bw/day
Sex:
male/female

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
White mineral oil (petroleum) is not a reproductive toxicant.
Executive summary:

A one generation reproductive toxicity study was performed in Sprague Dawley rats to determine the effects of two EDS coal liquids. In this study, a white mineral oil (petroleum) was used as a vehicle control group for each test material in the study. Only the results of the white mineral oil control groups (one for each of the test materials) are summarized here.

Each of the two separate vehicle control groups contained male and female Sprague-Dawley rats. The dosed animals were given a single daily dose of 5 ml/kg (bw) of the white mineral oil. Dosing was done via gavage, 5 days/week for 13 weeks. After 13 weeks of dosing, the animals were mated. The mated females were maintained without further dosing through gestation and lactation to post-partum day 21. Gross observations of pups and dams were generally unremarkable. No treatment-related effects on the reproduction of parental rats or in the growth of F1 offspring were observed. The NOEL for both the parental and F1 offspring was determined to be >5ml/kg (approximately >4350 mg/kg/bw/day). Substance identity details supporting the use of 1white mineral oil (CAS No. 8042-47-5) as read-across can be found in ‘Section 13-Assessment Reports’ of the IUCLID dossier.