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Administrative data

Description of key information

Oral
WoE: LD50 oral >2000 mg/kg bw (Cognis, Potokar, 1983, Ac. Tox. oral, RL4)
WoE: LD50 oral >2000 mg/kg bw (RA-S, CAS 68424-31-7, Robinson, 1991 Croda, Ac. Tox. oral, RL4)
WoE: LD50 oral: >2000 mg/kg bw (RA-S, CAS 131459-39-7, Croda, Allen, 1999, Acute oral, rat, RL2)
Dermal
LD50 dermal >2000 mg/kg bw (RA-S, CAS 131459-39-7, Key, Croda, Allen, 1999, acute dermal, rat, RL1)
Inhalation
LD50 inhalation > 5100 mg/m3 air (aerosol) (RA-S, CAS 85536-35-2, Key, Croda, Parr-Dobrzanski, 1994, acute tox: inhal, rat, RL1)

Key value for chemical safety assessment

Additional information

Acute Oral toxicity:

The study conducted with the test substance (Cognis, Potokar, 1983, Ac. Tox. oral, RL4) revealed the oral LD50 to be higher than 2000 mg/kg bw. Although this study was conducted with a reduced amount of animals (2 male and 2 female), the results are considered adequate in combination with the read-across data of the structural analogues, the CAS numbers 68424-31-7 and 131459-39-7.

The study conducted with CAS No.68424-31-7 (RA-S, CAS 68424-31-7, Croda, Robinson, 1991, Ac. Tox. oral, RL4) had the same limitations (reduced animal number), but revealed similar results.An initial weight loss was observed after treatment of rats with2000 mg/kg bw, but this effect was completely reversible and the animals showed subsequently normal body weight gain.

Treatment of rats with 2000 mg/kg bw of CAS 131459-39-7 (RA-S, CAS 131459-39-7, Key, Croda, Allen, 1999, Acute oral, rat, RL2) did not cause adverse effects in a study conducted according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).

Taken together, the available data on acute oral toxicity confirmed that the substance with CAS No. 85116-93-4 is not acute toxic if applied orally.

Acute Dermal toxicity:

The substance with the CAS number 131459-39-7 is a structural analogue of CAS 85116-93-4 and can therefore be used for read-across (RA-S, CAS 131459-39-7, Key, Croda, Allen, 1999, acute dermal, rat, RL1). The semiocclusive application of 2000 mg/kg bw of CAS 131459-39-7 for 24 h (according to OECD 402) did not cause any adverse effects in rats implicating that CAS No. 85116-93-4 is not acute toxic if applied on skin.

 

Acute Inhalation toxicity:

The substance with the CAS No. 85536-35-2 is a structural analogue of CAS No. 85116-93-4 and can therefore be used for read-across (RA-S, CAS 85536-35-2, Key, Croda, Parr-Dobrzanski, 1994, acute tox: inhal, rat, RL1).

Rats were exposed nose only for 4 hours to approx. 5 mg/L (analytical concentration of the aerosol of the test material). No mortality occurred and no signs of systemic toxicity were observed. Clinical signs seen during and/or immediately after exposure were hunched posture, chromodacryorrhea, piloerection, stains around the nose and wet fur. In general, animals showed a rapid recovery from these effects by day 2, although, hunched posture and piloerection persisted in few animals to days 4 and 8, respectively.

Justification for classification or non-classification

Taken together in a Weight of Evidence approach, Fatty acids, C16-18, esters with pentaerythritolt (CAS No. 85116-93-4) are not acute toxic.

According to the criteria of the CLP and DSD regulation, no classification is warranted.