Registration Dossier

Administrative data

Description of key information

Acute Toxicity- Oral LD50 = 22930 mg/kg in rats

Acute Toxicity- Dermal LD50 = 4983 mg/kg in rabbits

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Qualifier:
no guideline followed
Principles of method if other than guideline:
Non-fasted animals were treated with a single dose by gastric intubation and observed during 14 days. This study was conducted as a range-finding test according to the method described by Smyth HF Jr. and Carpenter CP (1948).
GLP compliance:
not specified
Test type:
standard acute method
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Mellon Institute
-Age at study initiation: 4-5 weeks
-Weight at study initiation: 90-120 g
-Diet: Rockland Rodent diet
Water: ad-libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Details on oral exposure: undiluted substance
Doses:
Logarithmic differing by a factor of 2 (no further detail)
No. of animals per sex per dose:
5 Males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily for mortality; frequency of weighing not specified.
- Necropsy of survivors performed: no
Statistics:
LD 50 calculated by method of Thompson (Bacteri Rev 11: 115 June 1947 Use of moving averages and interpolation to estimate median effective dose) and tables of Weil (Biometrics 8: 249 Sept 1952: Tables for convenient calculation median-effective dose (LD50 or ED50) and instructions in their use). The LD50 is given with ± 1.96 standard deviations.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
22 932 mg/kg bw
Based on:
test mat.
95% CL:
> 18.9 - <= 35.8
Remarks on result:
other: original data: 26.0 ml/kg LD50 (mg/kg)= LD50 (ml/kg) x density x 1000 = 26.0 x 0.882 x 1000 = 22932.0 mg/kg
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for n-hexyl acrylate following oral intubation was established at ca. 22392 mg/kg bw (26.0 mL/kg) for males. This finding does not warrant classification of n-hexyl acrylate as an acute oral toxicant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Executive summary:

In the key study (Smyth 1969), male rats were treated orally with single doses of n-hexyl acrylate and observed during 14 days. This study was conducted as a range-finding test according to the method described by Smyth HF Jr. and Carpenter CP (1948). The LD50 for n-hexyl acrylate following oral intubation was established at ca. 22392 mg/kg bw (26.0 mL/kg) for males. This finding does not warrant classification of n-hexyl acrylate as an acute oral toxicant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
22 930 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Principles of method if other than guideline:
Male albino rabbits (3-5 months old) were immobilized during the 24-hour contact period with the compound retained under impervious sheeting on the clipped intact skin of the trunk. Thereafter, excess fluid is removed to prevent ingestion and animals are observed for 14 days.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.5 - 3.5 kg
- Fasting period before study: not specified
- Housing: not specified
- Diet (e.g. ad libitum): Rockland Rabbit Ration
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Details on dermal exposure: Male albino rabbits, 3 to 5 months of age are immobilized during the 24-hour contact period with the compound retained under impervious sheeting on the clipped intact skin of the trunk. Thereafter, the polyethylene sheeting used to retain the dose in contact with the clipped skin of the trunk was removed and the animals were observed for 14 days. Maximum dosage that can be achieved is 20 ml/kg

Duration of exposure:
Duration of exposure: 24 hours

Doses:
Logarithmic differing by a factor of 2 (no further detail)
No. of animals per sex per dose:
No. of animals per sex per dose: 4

Control animals:
no
Details on study design:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed daily for mortality; frequency of weighing not specified.
- Necropsy of survivors performed: no
Statistics:
LD 50 calculated by method of Thompson (Bacteri Rev 11: 115 June 1947 Use of moving averages and interpolation to estimate median effective dose) and tables of Weil (Biometrics 8: 249 Sept 1952: Tables for convenient calculation median-effective dose (LD50 or ED50) and instructions in their use). The LD50 is given with ± 1.96 standard deviations.
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
4 983 mg/kg bw
Based on:
test mat.
95% CL:
> 3.5 - < 9.14
Remarks on result:
other: original data: 5.65 ml/kg LD50 (mg/kg)= LD50 (ml/kg) x density x 1000 = 5.65 x 0.882 x 1000 = 4983 mg/kg
Interpretation of results:
GHS criteria not met
Conclusions:
N-hexyl acrylate was administered via oral intubation to 4 male New Zealand White Rabbits to assess the acute oral toxicity. Animals were observed daily for 14 days post dosing. The LD50 for N-hexyl acrylate based on these data were established at 4893 mg/kg (5.65 ml/kg) for males. This finding does not warrant classification of N-hexyl acrylate as an acute oral toxicant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Executive summary:

N-hexyl acrylate is minimally toxic via ingestion where the LD50 was established at >2000 mg/kg in a range finding study. This finding does not warrant classification n-hexyl acrylate as an acute oral toxicant under the Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 983 mg/kg bw

Additional information

Justification for classification or non-classification

The LD50 for n-hexyl acrylate was established at 22930 mg/kg following oral intubation and 4983 mg/kg following dermal application. These findings do not warrant the classification of n-hexyl acrylate as an Acute toxicant under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).