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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

There are there studies available, two in mice and one in rats that give an indication of the acute oral LD50, this is sufficient for classification and labeling.  Extremely low dermal penetration testing indicates that acute dermal toxicity would be low and certainly lower than oral toxicity.  Inhalation data is not available but not required due to low potential for exposure via inhalation in industrial use of the substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Used four mice per dose level with four dose levels
GLP compliance:
no
Test type:
other: Calssical LD50 according to method of Weil (1952)
Species:
mouse
Strain:
other: ddY strain
Sex:
male
Details on test animals or test system and environmental conditions:
Male mice 5-6 weeks of age, 29+/- 2.2 g bodyweight
Route of administration:
oral: gavage
Vehicle:
DMSO
Doses:
Not specified
No. of animals per sex per dose:
4 males
Control animals:
not specified
Statistics:
Weil CS (1952) Tables for convienient calculation of medial effective dose (LD50 or ED50) and instructions for their use. Biometrics 8: 249-263

Oral LD50 calculated as 6.6 mmol/kg with 95% confidence interval (3 -1 - 9.2). Based on the molecuilar weight of 183.29 this was 1210 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 210 mg/kg bw
Quality of whole database:
The data set is of acceptable quality to allow for the correct classification of the product under the EU CLP (GHS) criteria.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The lack a data is acceptable as there is very low possibility of inhalation exposure within the European Union. As N-(1,1,3,3-tetramethylbutyl)acrylamide is only handled incorporated in polymers.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
The data set is of acceptable quality to allow for the conclusion that N-(1,1,3,3-tetramethylbutyl)acrylamide would not be classified under the EU CLP (GHS) criteria for acute dermal toxicity.

Additional information

There are there studies available, two in mice and one in rats that give an indication of the acute oral LD50, this is sufficient for classification and labeling. The physical chemical properties of the N-(1,1,3,3-tetramethylbutyl)acrylamide, mean that significant inhalation exposure is not expected so acute inhalation toxicity testing is not justified or required. The extremely low dermal absorption indicated that acute dermal toxicity would be low and based on the oral data below the level requiring classification under the EU CLP (GHS) criteria.

Justification for selection of acute toxicity – oral endpoint

As well as the accurate oral LD50 in mice of 1210mg/kg there is data from a dose ranging study with repeat doses in rats up to 1000mg/kg. Based on this study the oral LD50 can be estimated to be greater than 500 mg/kg day and less than 1000 mg/kg/day.   Also in the dose range finding for the mouse micronucleus study the results indicated an oral LD50 value between 700 and 800 mg/kg.  All these values indicate an oral LD50 in the classification range of EU CLP (GHS) Category 4.

Justification for selection of acute toxicity – inhalation endpoint

N-(1,1,3,3-tetramethylbutyl)acrylamide CAS 4223-03-4 has a relatively low vapour pressure of 0.0636 Pa at 20 °C. Its use as a monomer outside the European Union where it is handles as a solution in ethanol has very little potential for inhalation exposure.  Data is available for acute oral exposure which indicates only moderate acute toxicity.

Justification for selection of acute toxicity – dermal endpoint

N-(1,1,3,3-tetramethylbutyl)acrylamide CAS 4223-03-4 has been shown to only penetrate human skin very slowly with rats showing three times the rate but still only 0.3%  was measured.  We have sufficient information for acute oral toxicity for classification and labeling and while we have no data on oral absorption it can be assumed to be significantly higher than dermal absorption.  Therefore based on the Oral LD50 in mice of 1210mg/kg acute dermal toxicity would be expected to well above 2000mg/kg

Justification for classification or non-classification

Therefore N-(1,1,3,3-tetramethylbutyl)acrylamide is only moderately acutely toxic by the oral route and is classified as category 4 under the EU CLP (GHS) criteria. The low dermal penetration indicates that acute dermal toxicity would not be expected to require classification. It is not justified to develop animal data for acute inhalation toxicity so it is not classified..