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Key value for chemical safety assessment

Effects on fertility

Description of key information

No relevant infrmation available.  A testing proposal has been submitted for an extended one-generation study

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available (further information necessary)
Additional information

Study proposal to fulfil the information requirements of REACH Annex IX (8.7.3). In a number of repeat dose (dermal) and several OECD 414 developmental toxicity studies there were no effects observed on development. In addition, no effects were observed on reproductive organs in subchronic studies with OGO and an assessment of the overall weight of evidence (as outlined in the attached testing proposal) concludes that it is unlikely that the primarily aliphatic OGOs have an adverse effect on fertility.

No guideline studies were located that have examined the potential impact of Other Gas Oils on reproductive function. Some indication of the likely effect of a test substance on reproductive organs can be gained from the results of repeated-dose toxicity studies with members of this category, which did not show any treatment related effects on reproductive (Table 1). Nevertheless, a testing proposal for an extended one-generation study with a representative sample for the category is included.

Table 1. Summaries of data on reproductive organs from subchronic studies with OGO (Robust study summaries are provided in IUCLID Section 7.5 Repeated Dose Toxicity)

Test Material

Route, Species, Doses, Exposure Regimen

Endpoints

Results

Reference

API 81-09

Hydrodesulfurized middle distillate

CAS 64742-80-9

Inhalation. Rat.

23 mg/m3, 6 hr/day, 5 days/wk, 4 wk

Weight of ovaries and testes. Histopathology of ovary, uterus, prostate, and testis.

No treatment-related effect except for “variation” in “absolute and/or relative” weight of testis. Body weight was unaffected. No further details were in summary report for Group III.

API, 1986

API 81-09

Hydrodesulfurized middle distillate

CAS 64742-80-9

Dermal. Rabbit.

200, 1000, or 2000 mg/kg/day, 3 days/wk, 4 wk

Weight of ovaries and testes. Histopathology of ovaries, vagina, uterus, testes, epididymides, prostate, and seminal vesicles.

No observed treatment-related effect on reproductive organs.

API, 1983

Short description of key information:

Study proposal to fulfill the information requirements of REACH Annex IX (8.7.3) with respect to reproductive toxicity. In a number of repeat dose (dermal) and several OECD 414 developmental toxicity studies there were no effects observed on development. In addition, no effects were observed on reproductive organs in sub chronic studies with OGO and an assessment of the overall weight of evidence (as outlined in the attached testing proposal) concludes that it is unlikely that the primarily aliphatic OGOs have an adverse effect on fertility.

Effects on developmental toxicity

Description of key information

In a read across developmental study from a straight-run petroleum gas oil, authors reported a NOAEL of 50 mg/kg body weight/day, based on significant decrease in pup body weight and increase in external, visceral, and skeletal malformations at a dose of 250 mg/kg body weight/day. The maternal LOAEL was 50 mg/kg body weight/day, based on dermal effects.  It is concluded that there is no evidence of developmental toxicity in the absence of significant maternal toxicity.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Additional information

No studies were located for OGO substances. However information from a dermal study in rats on a Straight-run gas oil (straight-run petroluem gas oil; CAS 64741 -43 -1) may be used as a source of information for read across. Straight run gas oil data can be used as read-across data for OGO substances due to similar physical/chemical properties and composition. 

In a key read across, developmental toxicity study (ARCO, 1993a), straight-run petroleum gas oil (F-193) in acetone was dermally administered to 25 presumed pregnant rats/dose at dose levels of 0, 50, 250, or 500 mg/kg bw/day from days 0 through 19 of gestation.

 

Skin reactions (erythmea, oedema, atonia, and desquamation) occurred in all treatment groups. There was a significant reduction in body weight and feed consumption in the 250 - and 500 -mg/kg/day groups.  There was also a significant reduction in average litter size and live foetuses, increased resorptions in these groups. 

The maternal LOAEL was 50 mg/kg/day, based on dermal effects. There was no maternal NOAEL. There was a significant decrease in pup body weight and increase in external, visceral, and skeletal malformations in the mid- and high-dose groups.The developmental LOAEL was 250 mg/kg/day, based on pup body weight and malformations. The developmental NOAEL was 50 mg/kg/day.

Justification for classification or non-classification

No reproductive toxicity data are available for other gas oils so there is insufficient information to classify this category as toxic for reproduction under the EU CLP Regulation (EC No. 1272/2008). An extended one-generation reproductive toxicity study is proposed for a representative sample of the category

A key read-across developmental study on a sample of a straight run gas oil was identified. The LOEL for maternal toxicity was 50 mg/kg based on local dermal effects. The NOAEL for foetal toxicity was 50mg/kg. No classification for effects on development is proposed however since there was no evidence of foetal effects in the absence of significant maternal toxicity.

Additional information

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