1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

No effects on fertility were observed in a screening study performed with the structural analogue Hosatvin 3055. Additionally, no histological alteration of reproductive organs was observed in a 28 day repeated dose toxicity study with the submission substance, indicating that the submission substance has no influence on fertility.

Link to relevant study records

Reference

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Specific details on test material used for the study:

Recalculation of the (no) effect dose has been performed on basis of the assumption that the purity of the target substance and source substance is 100%; i.e. purity has not been considered for the recalculation.

Key result

Dose descriptor:

NOEL

Effect level:

>= 110 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

clinical signs

mortality

body weight and weight gain

clinical biochemistry

organ weights and organ / body weight ratios

gross pathology

reproductive function (oestrous cycle)

reproductive function (sperm measures)

reproductive performance

Remarks on result:

not determinable due to absence of adverse toxic effects

Key result

Dose descriptor:

NOEL

Generation:

F1

Effect level:

>= 110 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

viability

clinical signs

mortality

body weight and weight gain

gross pathology

Remarks on result:

not determinable due to absence of adverse toxic effects

Key result

Reproductive effects observed:

no

Conclusions:

Under the conditions of this Reproduction / Developmental Toxicity Screening Test, a ‘No Observed Effect Level’ (NOEL) for reproductive toxicity is considered to be highest dose employed in the study i.e.,100 mg/kg/day for the source substance (110 mg/kg bw/day for target substance).

Executive summary:

The study used as source investigated the reproductive/developmental toxicity of Hostavin 3055.The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

sufficient for evaluation

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

An OECD 421 “Reproduction/Developmental Toxicity Screening Test " has been performed with the structural analogue Hostavin 3055.

The test item (formulated in refined ground nut oil) was administered by oral gavage to three groups, each of twelve male and twelve female Wistar rats, for up to 42 days for males, up to two weeks premating phase, two weeks pairing, three weeks gestation and 13 days lactation for females, at dose levels of 5, 25 and 100 mg/kg/day. A control group of ten males and ten females were dosed with vehicle control (Refined ground nut oil).

No test item related effects on fertility or offspring was observed up to the highest dose tested (NOAEL 100 mg Hostavin 3055/kg bw/day or 110 mg submission substance/kg bw/day).

Additionally, no effects on reproductive organ histopathology was observed in a repeated 28 day toxicity test with the submission substance.

Based on these observations it is concluded that the submission substance has no effect on reproductive performance.

Effects on developmental toxicity

Description of key information

No studies on developmental toxicity of the submission substance have been identified. In an OECD 421 screening study no effects on offspring were observed up to the highest dose (100 mg/kg bw/day) tested.

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:

no study available

Additional information

Database insufficient for evaluation, developmental toxicity study missing, see study proposal.

Mode of Action Analysis / Human Relevance Framework

In the absence of any indications on species specific toxicity or mode of action the available data are regarded as relevant for humans.

Justification for classification or non-classification

Based on the available data, which do not point to any adverse effect on fertelity and development, no classification of the submission substance for reproductive toxicity according to Regulation (EC) No 1272/2008 is required.