Reaction mass of 2,2'-[(4-methylphenyl)imino]bisethanol and Ethanol, 2-[[2-(2-hydroxyethoxy)ethyl](4-methylphenyl)amino]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 9th - November 9th, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes (incl. QA statement)

Remarks:

issued 31JAN1994

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2,2’-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4- methylphenyl)amino]-

IUPAC Name:

Reaction mass of 2,2’-[(4-methylphenyl)imino]bisethanol and Ethanol 2-[[2-(2-hydroxyethoxy)ethyl](4- methylphenyl)amino]-

Test material form:

liquid: viscous

Details on test material:

Physical appearance: colourless viscous liquid
Storage conditions: At room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK)
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 137 - 181g; females 132 - 154g
- Fasting period before study: o/n before dosing and 2 hours after dosing
- Housing: group-housed (up to 5 of same sex)
- Diet: ad libitum (Rat and mouse expanded diet No.1, special diets services limited, Witham, Essex, UK)
- Water: ad libitum
- Acclimation period: minimal 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 44-57
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 1.86 ml/kg

Doses:

500, 1000, 2000 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
- Frequency of observations and weighing: Animals were observed for deaths 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual body weights were recorded on the day of dosing and on days 7 and 14.
- Necropsy of survivors performed: yes (gross pathology)
- Other examinations performed: clinical signs, at 0.5, 1, 2 and 4 hours after dosing and subsequently once daily.

Statistics:

The LD50-value was calculated using a probit method of Finney, DJ: "Probit Analysis", 1971, Cambridge University Press. The LD50 and 95% confidence limits were calculated for males only.

Results and discussion

Preliminary study:

No mortality was observed in the range-finding study.

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

619 mg/kg bw

Based on:

test mat.

95% CL:

>= 305 - <= 1 256

Remarks on result:

other: Male animals were considered to be more sensitive to the test material than female animals.

Mortality:

At 2000 mg/kg bw, all males died and 3/5 females.
At 1000 mg/kg bw, 3/5 males died (only males treated) and at 500 mg/kg bw 2/5 males died (at these dosages, only males were treated).
Mortality occurred within half an hour after dosing.

Clinical signs:

other: Common signs of systemic toxicity noted in the surviving animals were hunched posture, decreased respiratory rate and laboured respiration with additional signs of ataxia. Lethargy was commonly noted in males treated with 1000 mg/kg and females treated wi

Gross pathology:

Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Cat. 4 according to EC Regulation 1272/2008

Conclusions:

In an acute oral toxicity test performed according to the OECD guideline, the LD50 of BISOMER PTE was found to be 619 mg/kg bw.

Executive summary:

An acute oral toxicity test was performed according to the OECD guideline, with male and female rats.

At the starting dose (2000 mg/kg bw) all males and 3/5 females died. At the lower doses only males were treated. At 1000 mg/kg bw 3/5 rats died, at 500 mg/kg bw 2/5 rats died. Death occurred in all animals within 0.5 hours after dosing. The surviving animals showed hunched posture, decreased respiratory rate and laboured respiration with additional signs of ataxia. Lethargy was commonly noted in males treated with 1000 mg/kg and females treated with 2000 mg/kg bw. These clinical signs disappeared within one or two days after exposure. Surviving animals showed expected gain in body weight during the study. Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study.

Based on an LD50 of 619 mg/kg bw, BISOMER PTE is classified for acute oral toxicity cat. 4 according to EC regulation No 1272/2008.