2-propylheptyl methacrylate

Endpoint summary

Description of key information

oral: LD50 (rat): >2000 mg/kg bw (BASF SE, 2014)
dermal: LD50 (rat): > 5000 mg/kg bw (BASF SE, 2014)

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: Young adult animals (approx. 10 weeks)
- Weight at study initiation: animals of comparable weight (+/- 20 %)
- Fasting period before study:
- Housing: single housing, Makrolon cage, type III
- Diet (e.g. ad libitum): ad libitum, VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females (1 Administration)
3 females (2 Administration)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight, pathology:

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred in both administration groups.

Clinical signs:

In the first 2000 mg/kg bw test group impaired general state and piloerection were observed from hour 0 or 1 until hour 5 in two animals, respectively. In the second test group impaired general state and piloerection were observed at hour 1 and 2 in one animal.
Three animals did not show any symptoms.

Body weight:

The mean body weight of the test groups increased throughout the study period within the normal range with three exceptions in both groups. One female of the first test group and two females of the second test group showed stagnation of body weight during the second week.

Gross pathology:

There were no macroscopic pathological findings in the animals sacrificed at the end of the observation period.

Mortality
Dose (mg/kg bw):	2000	2000
Sex:	female	female
Administration:	1	2
No. of animals	3	3
Mortality (animals):	No mortality	No mortality

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

GLP guideline study

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: male approx. 8 weeks; female approx. 12 weeks
- Weight at study initiation: animals of comparable weight (+/- 20%)
- Housing: single housing (Makrolon cage, type III)
- Diet (e.g. ad libitum): ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 40 cm²
- % coverage: 10 %
- Type of wrap if used: semi-occlusive dressing (air-permeable dressing (4 layers of absorbent gauze (Ph. Eur.) and stretch bandage (Fixomull® Stretch (adhesive fleece)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 24 hours, with warm water

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs, body weight,pathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

No signs of systemic toxicity or skin effects were observed.

Body weight:

The mean body weight of the animals increased within the normal range throughout the study period with two exceptions in the female group. One female lost weight and another one stagnated during the first week, but body weights were within the normal range during the second week.

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

GLP guideline study

Additional information

Oral:

In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg bw of the undiluted test item 2-Propylheptyl methacrylate was administered to two test groups of three fasted Wistar rats by gavage according to OECD guideline no. 423. The following test substance-related clinical observations were recorded (2000 mg/kg): No mortality occurred. Impaired general state in three animals. Piolerection in three animlas. The mean body weight increased withhin the normal range throughout the study period with three exceptions in both groups. One female of the first test group and two females of the scond test group showed stagnation of body weight during the second week. There were no macroscopic pathological findings at the end of the observation period. The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.

Inhalation:

no data

Dermal:

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw of the undiluted test item 2-Propylheptyl methacrylate to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours according to OECD guideline no. 402. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. No mortality was occurred. No signs of systemic toxicity were observed. The mean body weight of the animals increased within the normal ragne throughout the study period with two exceptions in the female group. One female lost weight and another one stagnated during the first week, but body weights were within the normal range during the second week. No macroscopic pathologic abnormalities were noted in the animals examined at eht end of the study. The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 5000 mg/kg bw.

Justification for selection of acute toxicity – oral endpoint
Key study

Justification for selection of acute toxicity – dermal endpoint
key study

Justification for classification or non-classification

Based on the results, 2 -Propylheptyl methacrylate is no subject to classification and labelling according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).