Butanal, 4-(heptyloxy)-3-methyl-

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

The toxicity to reproduction and developmemtal toxicity of the test substance TM 09 -217 were investigated in a reproductive/developmental tixicity screening study according to OECD test guideline 421 in CD rat by dietary administration. The animals were exposed to the test substance via diet for 4 weeks before mating. After mating the males continued under the diet with test substance till necropsy at week 10. Females continued under the diet with test substance till necropsy on day 7 of lactation. The dietary concentration of test substance were 490, 4900 and 14000 ppm and each group had 10 animals per sex.

The appearance and behaviour of the animals was unaffected by treatment and there were no premature deaths.

Slightly reduced bodyweight gain was recorded for males receiving 14000 ppm during the first two weeks of treatment, when compared with the controls. The overall weight gain (week 1 to 9), was similar to controls for males except the group given 14000 ppm which were lower than controls. For females, the overall weight gain (week 1 to 4) was similar to that of the controls in all treated groups, except for females given 14000 ppm which were slightly lower than controls. Bodyweight gains were similar to the control values during gestation, except for during Days 10 to 14 when they were significantly higher for females receiving 4900 or 14000 ppm. During lactation, bodyweight gains were increased for females receiving 4900 ppm, but were low for females given 490 or 14000 ppm from Day 4 of lactation.

Food consumption was low in females receiving 14000ppm for the first three days of treatment, and in males at this dose level, food intake was slightly low for the first day of treatment. Food consumption for females treated with TM 09-217 was generally similar to that of the controls during gestation. Food intake was slightly low for females receiving 14000 ppm during lactation, especially on the first day.

Organ weight assessment for males revealed statistically significant high kidney and liver weights at 14000 ppm and liver weights at 4900 ppm. For females during lactation, kidney and liver weights were also higher than the controls at 4900 or 14000 ppm.

Hypertophy seen histologically in the livers of females correlates with the increased liver weight seen in females treated with 14000 ppm. There was no histological correlate for the increased liver weight seen in males treated 14000 ppm. Vacuolation of the corticomedullary tubules seen histologically in the kidneys of females correlates with the increased kidney weight seen in females treated with 14000 ppm. There was no histological correlate for the increased kidney weight seen in males treated with 14000 ppm. Corticomedullary vacuolation seen histologically in females given 14000 ppm correlates in some cases with the pale kidneys seen macroscopically. A trackdown work of livers and kidneys in females given 4900 ppm adn 490 ppm are underway. Generally those types of hitopathological finding are considered as non-adverse effects.

No treatment related histological changes were observed in the testes and epididymis in males or in the ovaries of females. In the males, the seminiferous tubules were evaluated with respect to their stage in the spermatogenic cycle and the integrity of the various cell types present within different stages.

There was no effect of the test material on oestrous cycles pre-coital interval, mating performance, fertility, gestation length or gestation index. There was not effect of the test substance on sperm in this study, including sperm count, motility and morphology.

Short description of key information:
The toxicity to reproduction of Starfresh was experimentally determined in a reproduction/developmental toxicity screening study in rats via diet according to OECD TG 421 with 4 week of premating treatment and total treatment of 9 weeks for males. No effects were observed on fertility, sperm count/motility/morphology or reproductive organs in both, and the findings in liver and kidney are not considered as adverse effects, therefore the NOAEL for reproductive toxicity and systemic toxicity are anticipated to be 14000 ppm (corresponging to 895 mg/kg bw in females and 870 mg/kg bw in males ) (the highest dose tested).

Effects on developmental toxicity

Description of key information

The developmental toxicity of Starfresh was experimentally determined in a reproduction/developmental toxicity screening study in rats via diet according to OECD TG 421 with 4 week of premating treatment. The NOAEL for systemic toxicity and developmental toxicity are anticipated to be 14000 ppm (corresponging to 895 mg/kg bw in females and 870 mg/kg in males) (the highest dose tested).

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

The toxicity to reproduction and developmemtal toxicity of the test substance TM 09 -217 were investigated in a reproductive/developmental tixicity screening study according to OECD test guideline 421 in CD rat by dietary administration. The animals were exposed to the test substance via diet for 4 weeks before mating. After mating the males continued under the diet with test substance till necropsy at week 10. Females continued under the diet with test substance till necropsy on day 7 of lactation. The dietary concentration of test substance were 490, 4900 and 14000 ppm and each group had 10 animals per sex.

Litter size, survival and sex ratio were not adversely affected by TM 09-217. At 14000 ppm, offspring bodyweights on Day 1 of age and growth of the pups to Day 7 of age were slightly low, when compared with the controls. The clinic data on the pups are not avaialble by now.

The finding of slight lower of the growth of the pups from day 1 to day 7 and slight lower body weight on day 1 at 14000 ppm could be related to lower food consumption in the mothers on lactation day 1 and slight larger litter size in the high dose group.

The changes in growth and body weight of the pups in the high dose was not big and may not present any biological significance, as there is no impact on viability index. In fact the index was the highest in the high dose group.

Justification for classification or non-classification

Based on the absence of adverse effects on fertility, sperm count/motility/morphology, reproductive organs and of developmental toxicity in the Reproduction / Developmental Toxicity Screening Test in rats via diet (4-week premating period with total treatment of 9 weeks in males), classification of the test material for effects on fertility or developmental toxicity is not warranted in accordance with EU Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.