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Administrative data

Description of key information

Oral: 
acute toxicity, oral, rat, OECD 401, LD50 > 2000 mg/kg bw (Cray Valley, Huntingdon, 1998, McRae L.A.)
acute toxicity, oral, rat, similar OECD 401, LD50 > 2000 mg/kg bw (BASF, 1991, Dr. Kirsch).
acute toxicity, oral, rat, similar OECD 401, LD50 > 5000 mg/kg bw (Cognis, Food and Drug research laboratories, 1985, Reagan E. L.).
acute toxicity, oral, rat, protocol not specified, LD50 > 500 mg/kg bw but ≤ 5000 mg/kg bw, note: 2000 mg/kg was not assessed (Cytec, Bio/Dynamics, 1984, Auletta C.S.).
Dermal:
acute toxicity, dermal, rabbit, protocol not specified, LD50 > >13,200 mg/kg bw (Cytec, Bio/Dynamics, 1984, Auletta C.S.)
Inhaltion:
No information on acute inhalation available for TMPeoTA.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
13 200 mg/kg bw

Additional information

Oral:

OECD conform studies:

In an acute oral toxicity study performed in accordance with GLP and OECD guideline 401(Cray Valley, Huntingdon, 1998, McRae L.A.), groups of Sprague Dawley rats (5/sex) were given a single oral dose of TMPeoTA undiluted at 2000 mg/kg bw. In a preliminary study, one male and one female received a single oral dose of TMPeoTA undiluted at 3200 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 8 days in the preliminary experiment and for 15 days in the main study. They were all macroscopically necropsied after death or sacrifice. In the preliminary experiment, the male rat died within 22 h of dosing. Macroscopic examination of the decedent animal revealed congestive changes (characterised by dark appearance/prominent blood vessels) in the subcutaneous tissue, brain, heart, liver and spleen. Congestion with gaseous distension and fluid contents were also noted in the stomach and along the alimentary tract. Such effects were not observed in the female rat. In the main study, piloerection was observed in all rats within five minutes of dosing. This sign persisted and was accompanied in rats later on Day 1 and/or at later intervals during the study by: hunched posture, waddling/unsteady gait, lethargy, pallid extremities, walking on toes, abnormal faeces, thin appearance, ungroomed appearance and dark colouring to eyes, seen in all rats. These signs were accompanied in one or more rats by increased salivation and swollen abdomen. Recovery of surviving rats, as judged by external appearance and behaviour, was complete in all females by Day 7 and in all males by Day 10. The oral LD50 for TMPeoTA is higher than 2000 mg/kg bw in rats.

Studies according to other protocols:

A limit test similar to OECD 401 was conducted to assess the acute oral toxicity of the test substance (BASF, 1991, Dr. Kirsch). Therefore 10 (5 female and 5 male) wistar rats received a single oral of 2000mg/kg bw TMPeoTA solved in olive oil via gavage. No moralities were observed during the following 14 day observation period. No other unusual findings were reported. The pathologic examination after the end of the experiment reveals nothing unusual. The LD50 was determined as > 2000mg/kg bw.

The above referenced testarticle was evaluated in another test for acute oral toxicity in male and female Sprague-Dawley rats (Cognis, Food and Drug research laboratories, 1985, Reagan E. L.). The test article was administered by gavage to each of ten rats at a level of 5.0 g/kg Body weight. One animal died by study day 2 following administration of the test article. All other animals survived the 15 day observation period. Diarrhea was observed at all animals but no unusual body weight development was observed. Some animals had also salivation and wet abdomen. Necropsy revealed no noteworthy findings. Based on this result , the acute oral LD50 of the test article is considered to be greater than 5.0 g/kg body weight.

A further study was conducted to assess the single oral toxicity of TMPeoTA in rats using the standard acute method (Cytec, Bio/Dynamics, 1984, Auletta C.S.). Therefore 2 Groups of 6 animals/dose (sex unspecified) received a single oral dose of 500 or 5000 mg/kg. Parameters evaluated included survival and clinical observations for 7 days post-dosing. No signs of toxicity were noted at the dose level of 500 mg/kg bw. However, at 5000 mg/kg bw extreme fecal staining was noted on day 1 in all surviving rats. Three of the six animals died at this dose level.  In conclusion, the single oral median lethal dose (LD50) of TMPeoTA in rats was determined to be >500 mg/kg bw.

Dermal:

Studies according to other protocols:

A study was conducted to evaluate the acute dermal toxicity of ethoxylated trimethylol propane triacrylate (TMPeoTA) in albino rabbits (Cytec, Bio/Dynamics, 1984, Auletta C.S.). A dermal application of 13,200 mg/kg TMPeoTA was applied to 4 rabbits. Parameters evaluated included mortality, clinical observations and body weight for a period of 7 days. No mortality was observed. Lack of food consumption was reported in one animal on days 5 and 6. In conclusion, the single dermal median lethal dose (LD50) of TMPeoTA was determined to be >13,200 mg/kg bw in rabbits.

 

Assessment of acute toxicity:

Oral: All study results point to acute oral toxicity above 2000 mg/kg bw. Therefore a very low acute toxicity is assumed.

Dermal: The information available for the available acute dermal toxicity study points to very low dermal toxicity.

Inhalation: No acute inhalation study available

Key study assignment:

Oral: There a few studies available assessing the acute oral toxicity. All studies result point to the same result, but only one study is conducted according to OECD guideline under GLP (Cray Valley, Huntingdon, 1998, McRae L.A.). As this study is also the latest conducted and very well documented study this study is assigned as key study.

Dermal: As there is only one relevant and reliable study available assessing the dermal toxicity this study (Cytec, Bio/Dynamics, 1984, Auletta C.S.) has been used as key study.

Inhalation: No acute inhalation study available

Justification for classification or non-classification

The available data for ethoxylated trimethylolpropane triacrylate (TMPeoTA). indicate a low acute toxic potential. As the oral LD50 for TMPeoTA is higher than 2000 mg/kg bw in rats and the acute dermal LD50 is above 13,200 mg/kg bw no classification is derived. No information on inhalation toxicity is available which can lead to classification, therefore a classification for this endpoint is not possible.

In summary TMPeoTA it is not classified according to DPD (67/548/EEC) and the GHS (Regulation (EU) 1272/2008).

Labelling for acute toxicity:

GHS: no classification

DSD: no classification