Isooctyl acrylate

Endpoint summary

Key value for chemical safety assessment

Effects on developmental toxicity

Description of key information

Three studies have been conducted relating to reproductive and developmental effects:
-Teratology Screen in Rats:  No definitive indication of teratogenic effects were noted in the fetuses.
-Combined Repeat Dose and Reproductive/Developmental
   Toxicity Screening Study:  NOAEL for Reproductive Effects was a 20% solution applied dermally.  This was the highest concentration tested.
-Repeat Dose 90-Day Oral Study in Rats.  NOAEL was 600 mg/kg.  There were no effects noted on reproductive organs.
	 

Additional information

Teratology Screen

In the Teratology Screen, pregnant female rats were exposed to IOA at 1000 mg/kg from days 6 to days 15 gestation in a limit test. Clear signs of maternal toxicity were noted as evidenced by effects of body weight, clinical signs and gross pathology. Apparent effects on food and water water consumption were also noted. No definitive indication of teratogenic effects were noted in the fetuses.  Any effects observed in the developing fetuses were believed attributable to the maternal toxicity.

 

Reproductive Screen

The reproduction screen was a dermal application to the backs of male and female rats. The animals were dosed for two weeks prior to mating, through mating until sacrifice. The animals were dosed at levels of 0%, 1%, 7.5%, 5%, 15% and 25% in acetone. The 25% dose was lowered to 20% after one week due to severe irritation. There were no test material-related significant differences observed for mating or female fertility indices, mean days to mate, or length of gestation.  There were no test material-related differences for male fertility based on the percent of pregnant females. There were no test material-related effects seen in the offspring. This includes viability, clinical signs, body weight, sexual maturation, gross pathology, histopathology,  

 

When IOA was administered dermally to rats in concentrations of 1%, 7.5%, 15%, and 20%, the NOEL for effects on reproductive performance and growth and development of offspring was 20%. There was no overt material toxicity at the highest dose level tested (20% IOA).

 

90-Day Study

The toxicity potential of IOA was evaluated in a 90-day repeat dose study in male and female Crl:WI(Han) rats. The study was conducted under GLP conditions. The test method was based on OECD 408 (1998). The test material was diluted in corn oil (vehicle) to the appropriate dose concentrations. Male and Female rats (10/sex/group) received 0 (vehicle), 40, 150, or 600 mg/kg/day of the test article via oral gavage for 90 days. Clinical observations (daily), body weight (weekly), food consumption (weekly), functional tests (week 12), ophthalmoscopic examination (pretest and week 13), haematology (prior to necropsy), clinical chemistry (prior to necropsy), urinalysis (at end of treatment), gross pathology (at necropsy), histopathology (at necropsy) and immunohistochemistry (at necropsy) were each examined.

 

Adrenal glands

Spleen

Brain

Testes

Epididymides

Thymus

Heart Uterus (including cervix)

Kidneys

Prostate1

Liver

Seminal vesicles including coagulating glands 1

Ovaries

Thyroid including parathyroid

 

No effects were noted in any of the reproductive organs. The NOAEL for human risk assessment is 600 mg/kg.

Justification for classification or non-classification

Based on these data, IOA does not meet the criteria for classification as a reproductive/developmental toxic substance per the DPD or CLP.