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Key value for chemical safety assessment

Effects on fertility

Description of key information
no data
Effect on fertility: via oral route
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Additional information

No studies on toxicity to reproduction were available on Alcohols, C9-11 (odd numbered) branched and linear by any route.

The Category hypothesis is that the long chain linear aliphatic alcohol family has at its centre an homologous series of increasing carbon chain length, which is associated with a consistency and predictability in the property data across the group, for the physicochemical, environmental and toxicological property data sets. In view of the structural and chemical similarities, it is considered that results from reproductive toxicity studies on single- or multiple-constituent alcohols with appropriate chain lengths could be read across to Alcohols, C9-11 (odd numbered) branched and linear.

 

In a combined repeat dose and reproductive/developmental toxicity screening test, performed in rats to draft OECD guideline 422 and to GLP, an oral NOAEL of 2000 mg/kg bw/day (the highest dose tested) was determined for dodecanol for both the parental and F1 generations (Hansen 1992a).

 

A one-generation study was carried out with docosanol in rats, following a protocol equivalent to OECD guideline 415 and to GLP. The NOAEL for the parental and the F1 generations was 1000 mg/kg bw/day, the highest dose tested (Iglesias, 2000b).

A read-across feeding study reported a lack of effects on the reproductive organs of rats receiving hexanol (NOAEL 1127 mg/kg bw/day) and no adverse effects were noted at any of the dose levels administered during the study(Scientific Associates Inc. 1966).

No studies on toxicity to reproduction were available on any of the long chain linear aliphatic alcohol family by the dermal or inhalation routes.

 

No two-generation reproductive toxicity studies were available for the long chain linear aliphatic alcohol family by any route.

Chronic and sub-chronic toxicity studies have shown that long chain alcohols (LCA) are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested. Rather than having separate values for the three endpoints, one endpoint “systemic effects” has been used instead. Since the NOAELs do not vary greatly across the category, one key study has been chosen as being representative of the whole category.

 

C6, hexanol has been chosen as the category representative because shorter chain molecules are usually regarded as more toxic when compared to structural analogues with longer carbon chain lengths.

In some cases the CAS and chemical identity stated refer to the SDA nomenclature for this substance. In REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR.


Short description of key information:
No reproductive toxicity studies were available on Alcohols, C9-11 (odd numbered) branched and linear. A reproductive screening test with dodecanol was without effect on parental or F1 rats at 2000 mg/kg bw/day (Hansen 1992a) and in a one-generation study with docosanol the NOAEL was 1000 mg/kg bw/day (Iglesias 2002b). A read-across feeding study reported a lack of effects on the reproductive organs of rats receiving Hexanol (NOAEL 1127 mg/kg bw/day) and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966).

Effects on developmental toxicity

Description of key information
No developmental toxicity studies were available on Alcohols, C9-11 (odd numbered) branched and linear by any route. A reproductive screening test with dodecanol was without effect on parental or F1 rats at 2000 mg/kg bw/day (Hansen 1992a). In a guideline study with Alcohols C7-11 branched and linear, the NOAEL for both maternal and developmental toxicity was 1440 mg/kg bw/day. Octanol gave an NOAEL for developmental toxicity of 1300 mg/kg bw/day, but maternal toxicity was seen at 130 mg/kg bw/day (Hellwig & Jackh 1997).
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Additional information

No developmental toxicity/teratogenicity studies were available on Alcohols, C9-11 (odd numbered) branched and linear by any route.

 

The Category hypothesis is that the long chain linear aliphatic alcohol family has at its centre an homologous series of increasing carbon chain length, which is associated with a consistency and predictability in the property data across the group, for the physicochemical, environmental and toxicological property data sets. In view of the structural and chemical similarities, it is considered that the results from a number of reliable developmental toxicity/teratogenicity studies on single- or multiple-constituent alcohols with appropriate chain lengths can be read across to Alcohols, C9-11 (odd numbered) branched and linear.

 

A prenatal developmental toxicity study, performed to OECD guideline 414 and to GLP, was performed in rats dosed orally by gavage on days 6 to 15 of gestation with one of two long chain linear aliphatic alcohols: Clinical signs indicative of maternal toxicity were seen with octanol at 130 mg/kg bw/day, the lowest dose tested, and an NOAEL of 1300 mg/kg bw/day (the highest dose tested) was seen for developmental toxicity. No maternal or developmental toxicity was seen with Alcohols C7-11 branched and linear at up to 1440 mg/kg bw/day and this top dose was therefore the NOAEL (Hellwig & Jackh 1997).

 

In a combined repeat dose and reproductive/developmental toxicity screening test, performed to draft OECD guideline 422 and to GLP, an NOAEL of 2000 mg/kg bw/day (the highest dose tested) was determined for dodecanol for both maternal and developmental toxicity (Hansen 1992a).

No reliable guideline studies on developmental toxicity/teratogenicity were available on any of the long chain linear aliphatic alcohol family by the dermal routes.

Chronic and sub-chronic toxicity studies have shown that long chain alcohols (LCA) are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested. Rather than having separate values for the three endpoints, one endpoint “systemic effects” has been used instead. Since the NOAELs do not vary greatly across the category, one key study has been chosen as being representative of the whole category.

 

C6, hexanol has been chosen as the category representative because shorter chain molecules are usually regarded as more toxic when compared to structural analogues with longer carbon chain lengths.

In some cases the CAS and chemical identity stated refer to the SDA nomenclature for this substance. In REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR.

Toxicity to reproduction: other studies

Additional information

No data

Justification for classification or non-classification

Based on the available data, Alcohols, C9-11 (odd numbered) branched and linear would not be classified as toxic to reproduction under Regulation (EC) No. 1272/2008 (CLP) or Directive 67/548/EEC (DSD). Tests on similar substances included in this category are also supportive of these results, which do not warrant classification for toxicity to reproduction under DSD or GHS criteria.