Registration Dossier

Administrative data

Description of key information

Acute toxicity: oral: Wil Research Laboratories, Inc. Acute Oral Toxicity Study in Albino Rats (1981); GLP; comparable to the OECD guideline 401.
Acute toxicity: dermal: Wil Research Laboratories, Inc. Acute Dermal Toxicity Study in Albino Rabbits (1971); comparable to the OECD guideline 402.
Acute toxicity: inhalation: Industrial BIO-TEST Laboratories, Inc. Acute vapor inhalation toxicity study, 62310-31-151-1006 in albino rats (1971); comparable to the OECD guideline 403.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
515 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
discriminating conc.
Value:
730 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
11 430 mg/kg bw

Additional information

Acute oral toxicity of carbonic acid, oxydiethylene diallyl ester to rats is moderate. The acute oral toxicity study in albino rats with 'diallyl 2,2'oxydiethyl dicarbonate' (dated 1981 -10 -22) was chosen as the key study for acute oral toxicity assessment because of its GLP compliance, a clear dose dependent response (four dose levels tested) and LD50 which was calculated for both sexes.

Acute dermal toxicity to rabbits is low. When the test substance was administered dermally at one dose level of 10 mL/kg bw to the nonabraded skin of 8 New Zealand White rabbits (4 males and 4 females), signs of systemic toxicity occurred (anorexia, adipsia, emaciation and decreased defecation) during the post dose observation period of 14 days. Three of eight animals were found dead on day 2 of the study. Positive gross pathologic findings were observed in four of eight of the test animals. From the data presented in the report the LD50 of the test substance is greater than 10 mL/kg bw (11,430 mg/kg). No acute inhalation toxicity LC50 level could be established because of one dose level tested with only 1 hour of exposure.

Justification for read-across from supporting substance RAV 7AT (diallyl 2,2'-oxydiethyl dicarbonate; CAS 142-22-3; EC 205-528-7): About 53 % of RAV 7MC (EC 700-742-1) consists of components that can be found in RAV 7NG (EC 700-483-4). About 60 % of RAV 7NG (EC 700-483-4) in turn consists of components that can be found in the commercial ADC grades known as RAV 7AT, Nouryset 200 and CR39. Merely from comparing the similar production processes of these substances it is apparent that RAV 7AT, RAV 7NG and RAV 7MC are closely related to each other. Finally, it can be assumed that the physical-chemical, toxicological and ecotoxicological properties of RAV 7MC and RAV 7AT will be very similar and as a result, read across is justified.

Justification for classification or non-classification

The classification is warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulations No 1272/2008.

DSD: Xn, R22; Harmful if swallowed;

GHS: Acute tox.oral Cat. 4