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EC number: 221-975-0
CAS number: 3302-10-1
Oral LD50 values of reliable rat studies lie within the range of 1160-3135 mg/kg bw, and a fixed dose rat study reports mortality and other toxic effects at 2000 mg/kg bw. In a reliable inhalation study no mortality was observed in rats exposed to saturated vapour (ca. 0.03 mg/L). No reliable data for the test substance are availbale for the dermal route.
Single oral doses of > 631 mg/kg bw were toxic to fasted rats,
producing clinical signs of toxicity and an increased mortality at doses
of > 1000 mg/kg bw. The LD50 was 1160 (1018 -1322) mg/kg bw
(Hüls AG, 1986).
The acute inhalation risk test demonstrates that no hazard has to be
expected from exposure to saturated vapour of 3,5,5 -trimethylhexanoic
acid at room temperature.
6 rats (3 males, 3 females) were exposed to a saturated atmosphere
(calculated to 0.03 mg/L) of the test substance for 7 h. Within the
observation period of 14 days, there was no mortality, but only slight
signs of toxicity during exposure. No organ damage was detected at
The oral LD50 values reported in reliable rat studies vary by a factor
of about 3 (Hüls, 1986: 1160 mg/kg bw (key study, RL1); Hoechst, 1970:
3135 mg/kg bw; RL2), which is not unusual in different studies. The
findings of the key study are supported by a (reliable) limit test,
which reports mortality of most of the animals and other overt signs of
toxicity at 2000 mg/kg bw (Exxon, 1997, RL2), a reliable acute toxicity
test with a rat LD50 of 1350 mg/kg bw (BASF AG, 1980) as well as by a
(not reliable) secondary report of an oral LD50 value of 1598 mg/kg bw
in rats (Exxon, undated).
Note: The application form may have influenced the result: Low acute
toxicity (high LD50) was observed, when the test compound was
administered as a 10 % solution in sesame oil (Hoechst 1970), while
higher intoxication resulted from the oral treatment with the undiluted
test material (Hüls 1986; Exxon 1997).
In a reliable study 6 rats (3 males, 3 females) were exposed to a
saturated vapour atmosphere (calculated to 0.03 mg/L) of the test
substance for 7 h. Within the observation period of 14 days, there was
no mortality, but only slight signs of toxicity during exposure. No
organ damage was detected at necropsy (BASF AG, 1980).
A value of > 3 mg/l (Exxon, undated) is reported only in secondary
sources. The original study is not available.
A dermal LD50 of > 2000 mg/kg bw for the test substance is reported in a
less reliable study (Exxon, undated, RL 4). This data are reported only
in secondary sources. The original study is not available
Based on the findings of the key study reporting an oral LD50 of 1160
mg/kg in rats the substance should be classified for acute oral
toxicicity Category 4 according to Regulation (EC) No 1272/2008.
Based on an inhalation LC0 in the key study of 30 mg/m3, the vapour
saturation concentration at room temperature, no classification
according to Regulation (EC) No 1272/2008 is required with respect to
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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