Benzeneacetyl chloride, 2,5-dimethyl-

Endpoint summary

Description of key information

study according to OECD test guideline 423; result: LD50 > 5000 mg/kg bw

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:

2006-11-26 to 2007-01-25

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:

17 December 2001

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, 33178 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 12 weeks approximately
- Weight at study initiation: 169 g- 186g
- Housing: The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding (J. Rettenmaier & So'hne, 73494 Rosenberg, Germany). The cages of the animals were placed on racks. The wood granulate was randomly checked for contaminants at regular intervals and the results have been stored at the Department for Laboratory Animal Services, Bayer HealthCare AG, 42096 Wuppertal, Germany. The analyses yielded no evidence of any adverse effects on the aim of the study. The cages were changed at least once a week.
- Historical data: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days
- Method of randomisation in assigning animals to test and control groups: The animals were assigned to their groups by randomization. The random list was based on evenly distributed chance numbers by a software application. The animals
were identified by labels on the cages stating study number, test compound, animal number, group number, etc. and by individual animal identification using permanent skin marking.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2°C
- Humidity (%): 55 ±5%
- Air changes (per hr): approx. 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2006-11 -22, To :2006-12-08

Route of administration:

oral: gavage

Vehicle:

other: tap water with 2% Cremophor EL

Doses:

2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily for an observation period of atleast 14 days. The weight gain of the animals was normally checked weekly until the end of the study.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, macroscopic examination

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Gross pathology:

The necropsies performed at the end of the study revealed no particular findings.

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

According to OECD guideline 423 the LD50 cut-off of (2,5-dimethylphenyl)-acetyl chloride is > 5000 mg/kg bw. (Category 5 / unclassified of the Globally Harmonized Classification System).

Executive summary:

In an acute oral toxicity study according to OECD test guideline 423, groups of 10-12 weeks old female Wistar rats (3/step) were given a single oral dose of the test item (100 % a.i.) in tap water with the aid of 2% Cremophor EL at doses of   2000 mg/kg bw and observed for 14 days.

Oral LD50 Females ≥ 5000 mg/kg bw

Limit test

The test item is of low Toxicity based on the LD50 in female Wistar rats.                                                                               

There were no treatment related clinical signs, necropsy findings or changes in body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 5 000 mg/kg bw

Quality of whole database:

guideline study; reliability and validity high

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

Acute toxicity oral:

In an acute oral toxicity study according to OECD test guideline 423, groups of 10-12 weeks old female Wistar rats (3/step) were given a single oral dose (100 % a.i.) in tap water with the aid of 2% Cremophor EL at doses of 2000 mg/kg bw and observed for 14 days.

Oral LD50 Females ≥ 5000 mg/kg bw

Limit test

[trade name]-acid is of low Toxicity based on the LD50 in female Wistar rats.                                                                               

There were no treatment related clinical signs, necropsy findings or changes in body weight.

Justification for classification or non-classification

Based on the available data (2,5-dimethylphenyl)-acetyl chloride does not need to be classified with regard to acute oral toxicity according to Regulation (EU) No. 1272/2008 (CLP).