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Administrative data

Description of key information

The oral LD50 of diisotridecyl adipate was determined to be > 15000 mg/kg bw (limit test) (Moreno/Mobil, 1978a).
The dermal LD50 of diisotridecyl adipate was determined to be > 5000 mg/kg bw (Moreno/Mobil, 1978b).
Inhalational toxicity is not expected due to the low vapor pressure of diisotridecyl adipate (data waiving: study technically not feasible/appropriate).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
15 000 mg/kg bw
Quality of whole database:
Reliability 2

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
20 mg/m³
Quality of whole database:
Klimisch 4

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
5 000 mg/kg bw

Additional information

Acute oral toxicity

The acute oral toxicity of diisotridecyl adipate was determined in a valid acute toxicity study using 5 male and 5 female Wistar rats each receiving 15 g/kg bw of the test material by oral gavage (limit test).

None of the animals died. Clinical signs (diarrhea, lethargy, oily bodies) were observed predominantly during day 0 to 5.

The acute oral LD50 was determined to be > 15000 mg/kg bw in rats (Moreno/Mobil, 1978a).

The read-across substance Bis(2 -ethylhexyl) adipate had a LD50 of 15000 mg/kg in mice (w) and 24600 mg/kg in rats (w). The male animals showed higher LD50 -values: 24600 mg/kg mice (m), 45000 mg/kg rats (m) (NTP, 1982). Therefore the oral LD50 -values for both substances are in the same order of magnitude and very high.

Acute dermal toxicity

The acute dermal toxicity of diisotridecyl adipate was determined in a valid acute dermal toxicity study using 10 New Zealand White rabbits each receiving a single dose of 5000 mg/kg bw of test substance (limit test). The exposure time was 24 hours followed by an observation period of 14 days. Before application of test substance, the clipped skin of half of the test animals was abraded. At the end of the exposure period, the skin was cleansed.

No mortality was observed during the test. Two animals showed signs of emaciation. Other clinical observations were diarrhea (4 animals), and in single animals lethargy and bloated abdomen. Body weight development was below normal.

The acute dermal LD50 was determined to be > 5000 mg/kg bw in rats (Moreno/Mobil 1978b).

For the read-across substance Bis(2 -ethylhexyladipate) the LD50 in rabbits was 15100 mg/kg (Smyth et al., 1951, cited in BUA, 1997.) . Thus both substances show a very low hazard for acute toxicity.

Acute Inhalation toxicity

The vapor pressure of diisotridecyl adipate is estimated to be 6.64E-07. Thus atmosphere concentrations which can be reached are too low to exert toxic effects. Nelson et. al. (1990) have investigated series of alcohols showing that alcohols with a chain length from C5 on upward do not cause toxic effects due to low atmosphere concentrations achievable (.Journal of the American College of Toxicology 1990 (9): 93-97; Toxicol and Industrial Health 1990 (6): 373-387) (data waiving: study technically not feasible).

BUA, 1997, Di-(2 -ethylhexyl)adipate, BUA-Bericht 196, S. Hirzel Wissenschaftliche Verlagsgesellschaft

Justification for classification or non-classification

Acute oral toxicity

The acute LD50 in rats was > 15,000 mg/kg bw. This exceeds by far the cut-off value for classification according to EU regulations (Directive 67/548/EEC and Regulation (EC) No 1272/2008.

Acute dermal toxicity

The dermal LD50 in rats was > 5000 mg/kg bw. This exceeds clearly the cut-off value for classification according to EU regulations (Directive 67/548/EEC and Regulation (EC) No 1272/2008.

Overall, the acute oral and dermal toxicity of diisotridecyl adipate is low and does not require classification.