Acetic acid, anhydride, reaction products with 1,5,10-trimethyl-1,5,9-cyclododecatriene

Endpoint summary

Description of key information

Acute oral toxicity: LD50 is >5000 mg/kg bw in an OECD TG 401

Acute inhalation toxicity: LC50 is >26000 mg/m3 which is derived from the acute oral LD50 using route to route extrapolation.

Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The selected study is the key (and only) study and is adequate to cover this endpoint

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The selected study is the key (and only) study and is adequate to cover this endpoint

Additional information

Acute oral toxicity

The acute oral toxicity in female and male rats was studied in accordance to a guideline similar to OECD TG 401 and GLP principles. The substance was administered orally to one group of ten rats (5 females and 5 males) at 5000 mg/kg. Signs observed included diarrhea, lacrimation, body drop, catatonia, hunched back, gnawing at forepaws, ataxia, hypersensitivity to touch, head tremors, exophthalmus, abnormal gait, piloerection, red exudate around oral cavity, and a yellow discoloration of the fur (ventral and genital area). None of the ten rats died at 5000 mg/kg. Necropsy did not show any abnormality. The acute oral toxicity (LD50) was determined to be >5000 mg/kg. 

Acute inhalation toxicity

No study on the test substance is available. In the present case, inhalation exposure will be less than dermal exposure because the substance has a low vapour pressure and dermal exposure is the more likely route of exposure. Using route to route extrapolation the inhalation toxicity can be derived as follows: an oral LD50 of >5000 mg/kg bw can be roughly converted into > 26000 mg/m3 (ECHA's CLP guidance, section, 3.1.3.3.5, 2017, using the formula: 1 mg/kg bw = 0.0052 mg/L/4h). In the present case 50/100% oral and inhalation absorption is used. The maximum saturated vapour pressure for the substance is 6,1 mg/m3 (0.06 Pa x 246 MW (mg/mol)) / (8.3 (R, gas constant) x 293 (°K)). This means that the substance cannot reach a concentration higher than 6.1 mg/m3 at 20°C. Therefore, an LC50 for inhalation cannot be reached 

Acute dermal toxicity

Acute dermal toxicity in female and male rats was studied in accordance to OECD TG 402 and GLP.  A group of ten rats (five males and five females) received a single topical application of the test substance, administered as supplied, at a dosage of 2000 mg/kg bodyweight for a duration of 24 hours. All animals were killed as scheduled and examined macroscopically on Day 15, the end of the observation period. There were no deaths or clinical signs following the dose level of 2000/mg/kg bodyweight. All animals gained weight throughout the study and no macroscopic findings were evident at the macroscopic examination at termination on Day 15. Very slight erythema was observed in one male and one female. The female exhibiting erythema also showed eschar/scabbing. Desquamation/exfoliation was observed in a further three animals. The acute dermal toxicity (LD50) was determined to be >2000 mg/kg. 

Justification for classification or non-classification

Based on the results available, the substance does not have to be classified for acute oral, inhalation or dermal toxicity according to EU CLP (EC No. 1272/2008 and its amendments).