Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Vapour pressure was predicted using QSAR models of EPI Suite and US EPA T.E.S.T (US EPA, 2018).

Vapour pressure:

0 Pa

at the temperature of:

25 °C

Predicted VP from MPBPWIN v.1.44 of EPiSuite v.4.11: VP range: 3.89E-26 to 2.84E-06 Pa at 25°C; weighted average: 1.47E-06 Pa at 25°C. Considering the likelihood of prediction errors for very low VP values below the cut-off of 1.33E-4 Pa in EPISuite, the individual and weighted average VP values were presented generically as less than the cut-off i.e., <1.33 E-4 Pa.

di-TMPTTA predictions at higher temperatures: 8.13E-05 Pa at 40°C; 3.18E-04 Pa at 60°C;1.03E-03 Pa at 70°C

Predicted VP from US EPA T.E.S.T v.4.2.1: VP range: 2.95E-09 to 1.33E-01 Pa at 25°C; weighted average: 0.07 Pa at 25°C.

Based on the individual or weighted average VP predictions from EPISuite and T.E.S.T, the test substance is overall considered to have low volatility. The individual prediction for the most volatile constituent, di-TMPTTA, which is also the major constituent of the test substance present at 20-70%, has been considered, to represent the worst case scenario. However, given that the test substance has operating conditions at higher temperatures (such as 60 and 70°C), and that the T.E.S.T QSAR model only allows prediction at 25°C, the individual VP predictions for di-TMPTTA at 25°C and higher temperatures from EPISuite, has been considered further for risk assessment.

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

appearance / physical state / colour

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Safety Data Sheet

Qualifier:

no guideline followed

GLP compliance:

no

Physical state at 20°C and 1013 hPa:

liquid

Colour:

Colorless to pale yellow

Odour:

other: ester acrylate

Substance type:

organic

Conclusions:

The substance is a colourless to pale yellow liquid with an ester acrylate odour.

Executive summary:

The substance is a colourless to pale yellow liquid with an ester acrylate odour.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Based on the study results, the acute oral LD50 of the test substance was determined to be 5000 mg/kg bw.

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The information requirements for this tonnage band is sufficiently met with the available data.

Endpoint conclusion:

no study available

Endpoint conclusion:

no study available

Oral

A study was conducted to assess the acute oral toxicity of the test substance according to OECD Guideline 401 and EU Method B.1. Five males and five females were administered a single oral dose of 5,000 mg/kg bw by gavage. Animals were observed for 14 d. On Day 1, pilo-erection was seen within 5 min of dosing along with increased salivation during 2 h after treatment. Low body weight gain during the first week of the study was recorded but all rats achieved anticipated weight gains between Days 8 and 15. No other clinical signs were observed and recovery, judged by appearance and behaviour, was complete by Day 3. Under the test conditions, the acute lethal oral dose of the test substance was > 5,000 mg/kg bw(Liggett 1989).

A further study was performed to assess the acute oral toxicity of the test substance to the rat according to OECD Guideline 401 and EU Method B.1. In a preliminary test, 2 rats (one male and one female) received a single oral gavage dose of the test substance at a dose level of 3,200 mg/kg bw. As results at this dosage indicated the acute lethal oral dose of the test substance to be greater than 3,200 mg/kg bw, a further group of 10 fasted rats (five males and five females) was similarly dosed at 5,000 mg/kg bw in the main study. No abnormalities were revealed at macroscopic examination on Day 15. Under the conditions of the study, the acute lethal oral dose to rats was > 5,000 mg/kg bw(McRae 1998).

Inhalation

The test substance has low vapour pressure so that normal processing and use conditions will not generate inhalation exposure. Furthermore, there are no spray applications of the substance. Acute inhalation exposure is therefore not expected to pose an issue for human health and no further testing is required for this endpoint, in accordance with Annex VIII, Section 8.5, Column 2 of the REACH legislation.

Dermal

The acute dermal toxicity testing is not needed as the substance does not meet the criteria for classification for acute toxicity and STOT SE for the oral route. This is also supported by the absence of any systemic effects in thein vivoskin sensitisation study available with the test substance. Moreover, given the physico-chemical properties of the test substance, the dermal LD50 value is less likely (due to lower absorption potential of dermal route) to be lower than oral LD50 or the oral doses showing clinical signs. Hence, testing via dermal route will less likely result in any additional hazard identification and testing is therefore considered unnecessary.

Based on the LD50 values obtained in acute oral toxicity studies conducted with the test substance, the substance is not considered to require classification for acute effects according to CLP (EC 1272/2008) criteria.