Registration Dossier

Administrative data

Description of key information

For n-hexyl methacrylate one acute toxicty study (oral) is availible (International Bio-Research, 1978).

In this valid acute oral toxicity study (According to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", by the Staff of the Division of Pharmacology, FDA, 1959)

groups of ten male and ten female SPF-Wistar rats (weight: 150 to 230 g) were given a single oral dose of 20 ml/kg n-hexylmethacrylate. Animals were then observed for 14 days.

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:
comparable to guideline study with acceptable restrictions
Remarks:
Referring to "Appraisal of the safety of chemicals in foods, drugs and cosmetics" by the Staff of the Division of Pharmacology, FDA, 1959
Qualifier:
according to guideline
Guideline:
other:
Version / remarks:
"Appraisal of the safety of chemicals in food, drugs and cosmetics", by the staff of the Division of Pharmacology; FDA, 1959
Principles of method if other than guideline:
The test item was applied undiluted via gavage once at test start.
Prior to administration of the test item, the animals were not fed for 16 hours.
The administration was followed by a observation period of 14 days.
Afterwards an necropsy was performed.
The test item is a clear liquid with a pH value of 6.0.

GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
SPF
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Paderborn
- Females (if applicable) nulliparous and non-pregnant: [yes/no] not specified
- Age at study initiation: not specified
- Weight at study initiation: 150 - 230 g
- Fasting period before study: 16 h
- Housing: individual housing
- Diet (e.g. ad libitum): ad libitum; Ssniff/ Intermast
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45 -55 %
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: no vehicle

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg
Doses:
20 mL/kg = 17,720 mg/kg (density: 0.885 g/cm³)
No. of animals per sex per dose:
10 male
10 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality: listed after 1, 2, 5, 7, 14 days; observations : 20 min, 1h, 3h, 24h, 7d, 14d; weighing at test start and termination (14 days)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs; observations : 20 min, 1h, 3h, 24h, 7d, 14d
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 17 720 mg/kg bw
Based on:
test mat.
Remarks on result:
other: original value: LD50: approx. 20 mL/kg bw (8 of 20 animals were dead after 14 days of observation
Mortality:
24h: 0/20
14d: 8/20 (8 days after administration)
Clinical signs:
Reduced activity, disturbed coordination, hyperthermia, diarrhea, piloerection
Body weight:
Test start: avarege weight 197.50 g
Termination: avarege weight 228.18 g
Gross pathology:
Deceased animals had a gastrointestinal flush.
Sacrificed animals showed no macroscopic anomalies.

The LD50 > 20 ml/kg bw equals to 17720 mg/kg bw(density 0.886 g/cm³)

Interpretation of results:
GHS criteria not met
Conclusions:
According to the test result: LD50 (14days / >17720 mg/kg bw): > 5000 mg/kg bw the test substance n-Hexyl methacrylate has to be classified as practically nontoxic in rats in respect of its acute oral toxicity.
Executive summary:

In an acute oral toxicity study ( According to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", by the Staff of the Division of Pharmacology, FDA, 1959)

groups of ten male and ten female SPF-Wistar rats (weight: 150 to 230 g) were given a single oral dose of 20 ml/kg n-Hexylmethacrylate. Animals were then observed for 14 days.

Oral LD50 Combined: > 20 mL/kg (equals to  >17720 mg/kg (density 0.886 g/cm3))

8 of 20 animals died within the first 8 days after administration of the test item. These animals showed a gastrointestinal flush. The sacrificed animals instead showed no macroscopic anomalies. The average bodyweight rose from 197.50 g to 228.18 g per animal.

n-Hexyl methacrylate led to a reduced activity, disturbed coordination, hyperthermia, diarrhea and piloerection 20 minutes after the administration. These symptoms were vanished after 24 hours and the surviving animals showed a normal behavior.

n-Hexyl methacrylate is of very low oral toxicity based on this LD50test in males and females.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
17 720 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral route

In an acute oral toxicity study (According to the "Appraisal of the safety of chemicals in foods, drugs and cosmetics", by the Staff of the Division of Pharmacology, FDA, 1959) similar to OECD 401 groups of ten male and ten female SPF-Wistar rats (weight: 150 to 230 g) were given a single oral dose of 20 ml/kg n-hexylmethacrylate. Animals were then observed for 14 days.

The oral was found to be LD50Combined: > 20 mL/kg (equals to  >17720 mg/kg (density 0.886 g/cm3)).

8 of 20 animals died within the first 8 days after administration of the test item. These animals showed a gastrointestinal flush. The sacrificed animals instead showed no macroscopic anomalies. The average bodyweight rose from 197.50 g to 228.18 g per animal.

n-hexyl methacrylate led to a reduced activity, disturbed coordination, hyperthermia, diarrhea and piloerection 20 minutes after the administration. These symptoms were vanished after 24 hours and the surviving animals showed a normal behavior.

n-hexyl methacrylate is of very low oral toxicity based on this LD50test in males and females.

Justification for classification or non-classification

According to the test result: LD50 (14days / >17720 mg/kg bw): > 5000 mg/kg bw the test substance n-hexyl methacrylate has to be classified as practically nontoxic in rats in respect of its acute oral toxicity.

According to the available data and CLP as well as US-GHS(2009) criteria, no classification is warranted for acute toxicity.