4-(2-acryloyloxy-ethoxy) benzophenone

Endpoint summary

Description of key information

The acute oral lethality of MTDID 32918 was evaluated in female Wistar rats.  The study was conducted according to OECD 423 in compliance with OECD GLP.  Two groups of rats (3 females/group) received 2000 mg/kg bodyweight MTDID 32918 “neat” as a liquid via oral gavage. Crystallization of MTDID 32918 was observed prior to dosing the second group and the test item was heated up and subsequently cooled down to obtain a liquid suitable for dosing. Animals were observed daily for clinical signs and mortality.  Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15.  No mortality occurred. Hunched posture, piloerection, and uncoordinated movements were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted in 2/6 animals on Day 1. The mean body weight gain shown by the animals over the study in-life period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements).

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

Study period:

2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

Remarks:

No deviations ocurred that negatively impacted the integrity of the study or results.

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 3M Company, Lot 30029 II
- Expiration date of the lot/batch: 25 July, 2020
- Purity test date: 03 May, 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light
- Stability under storage conditions: Stable
- Stability under test conditions: Stable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test article was dosed neat.

FORM AS APPLIED IN THE TEST: Neat

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: 148-201 g
- Fasting period before study: None
- Housing: On arrival and following assignment to the study, animals were group housed (up to 3 animals of the same sex and same dosing group together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany) equipped with water bottles. The room in which the animals were kept was documented in the study records. Animals were separated during designated procedures/activities. Each cage was clearly labeled
- Diet (e.g. ad libitum): Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days
- Method of randomisation in assigning animals to test and control groups: Animals will be assigned to the study at the discretion of the coordinating biotechnician, with all animals within ± 20% of the sex mean body weights. Animals in poor health or at extremes of body weight range will not be assigned to the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24 C
- Humidity (%): 40-70
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 29 October, 2019 To: 28 January 2020

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSAGE PREPARATION: Neat

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 females

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 clinical signs and mortality. Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

No statistical analysis will be performed (The method used is not intended to allow the calculation of a precise LD50 value).

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality ocurred during the study.

Clinical signs:

other: Hunched posture, piloerecdtion and uncoordinated movments were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted for two out of six animals on Day 1.

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements).

Executive summary:

The acute oral lethality of MTDID 32918 was evaluated in female Wistar rats.  The study was conducted according to OECD 423 in compliance with OECD GLP.  Two groups of rats (3 females/group) received 2000 mg/kg bodyweight MTDID 32918 “neat” as a liquid via oral gavage. Crystallization of MTDID 32918 was observed prior to dosing the second group and the test item was heated up and subsequently cooled down to obtain a liquid suitable for dosing. Animals were observed daily for clinical signs and mortality.  Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15.  No mortality occurred. Hunched posture, piloerection, and uncoordinated movements were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted in 2/6 animals on Day 1. The mean body weight gain shown by the animals over the study in-life period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements).

Justification for classification or non-classification

Based on the results of the acute oral lethality study indicating a rat oral LD50 of > 2000 mg/kg bw, AEBP is classified as GHS Category 5.