Bis[(3,4-epoxycyclohexyl)methyl] adipate

Endpoint summary

Description of key information

Oral Toxicity: Read-across to structurally similar substance, Kern (1999)

The results of this study indicate that the LD50 of the test material was found to be approximately 5000 mg/kg in fasted male and female albino rats when administered once orally via gavage. Based on these results, it was not necessary to classify the test material according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Oral Toxicity: Read-across to structurally similar substance, Kern (1999) (Key Study)

The acute oral toxicity of the test material was investigated in accordance with the standardised guidelines OECD 401 and EPA OPPTS 870.1100, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997).

In a study conducted by Kern (1999), the acute oral toxicity of the test material was evaluated in a single-dose study in rats. The test material was administered once orally via gavage to groups of five male and five female fasted albino rats at dose levels of 2959 and 5000 mg/kg. The animals were observed at regular intervals for up to 14 days following administration to ascertain any changes in body weight or clinical behaviour. At termination of the study after 14 days, the animals were necropsied and any changes in the major organs was recorded.

3 males and 2 females in the 5000 mg/kg group died within six days of dosing. Mortality was 0/10 and 5/10 for the 2959 and 5000 mg/kg groups, respectively. Clinical findings were noted in both dose groups during the first week of the study with observations including various discoloured areas due to discharges/excretions, hypoactivity and/or impaired muscle coordination. Animals in the higher dose group were noted with decreased defecation, decreased urination, laboured respiration and/or convulsions. All animals appeared normal by day 6 and throughout the remainder of the study. Three animals that died were noted with gastric abnormalities. There were no other internal gross necropsy findings for animals found dead.

The LD50 of the test material was found to be approximately 5000 mg/kg in fasted male and female albino rats when administered once orally via gavage. Since the median lethal dose estimate was much higher than the test guideline limit, it was not necessary to classify the test material according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.

Oral Toxicity: Read-across to structurally similar substance, Bucch (1981) (Supporting Study)

In the study conducted by Buch (1981), the acute oral toxicity of Celloxide 2021 was investigated in groups of fasted male and female rats of the Charles River CD strain at dosages within the range 3500 - 5500 mg/kg. The test material was administered at a variable volume-dosage in maize oil on Day 1. Mortality and signs of reaction to treatment were recorded during a 14-day period of observation.

Under the conditions of this study the acute oral median lethal dosage (LD50) was greater than 5000 mg/kg. Based on these results, the test material does not require classification according to Regulation EC No. 1272/2008 or Directive 67/548/EEC.

Supporting Study

The acute oral toxicity of the test material was investigated by dosing to unfasted male rats with dose levels that differed by a factor of 2.0 in a geometric series

Soon after dosing, the rats became sluggish and were unsteady in gait. Deaths occurred by the morning after dosing. At autopsy gross pathological examination disclosed congestion of the lungs and the abdominal viscera. Burned areas were evident on liver surfaces that lay in apposition to stomachs which still contained part of the dose.

Under the conditions of this study the LD50 of the test material was 4.29 mL/kg bw (95 % confidence limits: 3.07-5.98 mL/kg).

Inhalation Toxicity

In accordance with section 8.5.2 of Column 2 of REACH Annex VIII, testing via the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. For the test material, exposure via the inhalation route is unlikely and it is therefore considered justified to omit this study.

Dermal Toxicity

In accordance with column 2 of section 8.5.3 of REACH, the acute dermal toxicity study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to acute toxicity.