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Description of key information

oral
LD50 rat: ca. 5140 mg/kg bw (Schmidt & Bachmann 1969)
inhalation
IHT, rat: 0/20 animals died after exposure to a saturated vapour atmosphere (Schmidt & Bachmann 1969, Val. 3)
IHT, guinea pig: 0/5 animals died after exposure to a saturated vapour atmosphere (Schmidt & Bachmann 1969, Val. 3)
dermal
LD50 guinea pig: > 17400 mg/kg bw (Smyth & Carpenter 1944, Val. 4)
LD50 rabbit: > 5000 mg/kg bw (Moreno 1976, Val. 4)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
5 140 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

There are reliable information given to assess the acute oral, inhalative and dermal toxicity of 2-ethylhexyl acetate (2-EHAc).

oral

Schmidt and Bachmann (1969) provided basic information on an acute oral study in rats. Here, technically pure 2-EHAc was administered to groups of 10 female albino rats. After four weeks of observation, the LD50 in rats is calculated as 5140 mg/kg bw. Mortality appeared predominantly within the first 24 h after application. Observed clinical signs were little excitation and narcosis. Animals that died showed an unspecific blood congestion in the interior organs. Survivors showed no treatment related effects at necropsy, but showed a marked body weight loss at the beginning of the observation period.

The LD50 level of 2-EHAc and other substances was estimated very roughly in an older study comparable to a range-finding study in rats (Smyth and Carpenter 1944, Val. 4). Doses of 2-EHAc were administered to groups of 6 male Wistar rats, differing with a spacing factor of 10. The tested doses were administered consecutively until two doses were found with either some/ complete mortality or no/some mortality. The LD50 level was then assessed by transferring the slope of probit mortality from an unreported structural analogue substance with more precise data. The LD50 for 2-EHAc is 3000 mg/kg bw but the method to assess the value is considered as not reliable.

inhalation

Basic information is available for two inhalation hazard tests with rats and guinea pigs (Schmidt & Bachmann 1969, Val. 3). Groups of 20 albino rats and 5 albino guinea pigs were exposed to saturated vapour atmospheres of 2-EHAc for eight hours. The concentration of this atmosphere is reported to be 7.5 mg/L at 27°C without any information about analytical measurements. Vapour saturation tresholds were determined for 20° and 30°C; these values were consistent with the reported test atmosphere. However, based on the available data for the vapour pressure, the calculated vapour saturation treshold is considerably lower (2.2 to 3.8 mg/L at 20 -25°C). For the inhalative tests, the publication is therefore of limited reliability.

Opposed results were provided by Smyth & Carpenter (1944, Val. 3) with only limited information. Again, groups of 6 male Wistar rats were exposed to a saturated vapour atmosphere for different time periods. Here, the maximum time period causing no mortality is 15 min. Following the description of the test method, the next time period which was tested (30 min) produced complete mortality. This result is inconsistent with the results of two other IHT described above. Furthermore, esters of acetic acid with various alcohols are generally of low inhalative toxicity; an IRT (8 hours exposure) with 2-ethylhexanol did not cause any deaths (Concentration calculated from vapour pressure: ca. 2.5 mg/L); the LC50 of acetic acid (inhalation for 4 hours) is 11.4 mg/L; the concentration of 2-ethylhexyl acetate in this IRT is probably around 2.2 - 3.8 mg/L (calculated from vapour pressure). It is therefore highly unlikely that the deaths observed at exposure times greater than 15 minutes can be attributed to exposure with 2-ethylhexyl acetate as this substance is generally of low acute toxicity and the informations available on the cleavage products and other acetates also does not indicate why deaths occured after this short time of exposure. The information presented in this publication is insufficient for assessment due to inconsistent results.

dermal

The dermal LD50 level of 2-EHAc and other substances was estimated very roughly in an older study comparable to a range-finding study in guinea pigs (Smyth and Carpenter 1944, Val. 4, see method described in the oral toxicity section). Doses of 2-EHAc were administered to groups of 6 guinea pigs under very harsh conditions (four days under occlusive conditions). The LD50 for 2-EHAc is > 17400 mg/kg bw. The method to assess a concrete LD50 value is considered as not reliable, but nevertheless the result indicate a very low dermal toxicity of 2-EHAc.

This assessment is supported by the result of a poorly reported study by Moreno (1976). Here, 2-EHAc was applied to a unknown number of rabbits under unknown conditions for a unknown period. The LD50 is >5000 mg/kg bw.


Justification for selection of acute toxicity – oral endpoint
key study

Justification for classification or non-classification

According to the available data and their reliability, 2-EHAc has not to be classified for its acute toxicity following 67/548/EEC and GHS requirements, respectively.

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