2,2'-[(4-methylphenyl)imino]bisethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Necropsy was not performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1987

Deviations:

yes

Remarks:

Necropsy was not performed.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[(4-methylphenyl)imino]bisethanol

EC Number:

221-359-1

EC Name:

2,2'-[(4-methylphenyl)imino]bisethanol

Cas Number:

3077-12-1

Molecular formula:

C11H17NO2

IUPAC Name:

2,2'-[(4-methylphenyl)imino]diethanol

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Wistar TNO W 74

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks (males); 14 weeks (females)
- Weight at study initiation: 166 - 189 g (males); 168 - 192 g (females)
- Housing: 5 animals/group were housed in macrolon typ III cages with wood granulat as bedding material
- Diet: Altromin R 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: Tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1.5
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSAGE PREPARATION:
The test substance was slightly heated prior to administration.

Doses:

0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mL/kg bw (equivalent to 109, 545, 1090, 1635, 2180 and 2725 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 signs of toxicity and mortality several times on the day of administration, twice daily thereafter and once daily on weekends and public holidays. The body weight was recorded prior to the administration and thereafter once weekly.
- Necropsy of survivors performed: no

Statistics:

Probit analysis was used for the calculation of the LD50 value.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

0.88 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Probit analysis

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

959 mg/kg bw

Based on:

test mat.

Remarks on result:

other: by calculation using a density of 1.09 g/cm³

Mortality:

109 mg/kg bw: no mortality occurred.
545 mg/kg bw: 2/5 males and 1/5 females died 1 h post-administration.
1090 mg/kg bw: 3/5 males and 2/5 females died 1 h post-administration.
1635 mg/kg bw: 4/5 males and 3/5 females died 1 h post-administration.
2180 mg/kg bw: 5/5 males and 3/5 females died 1 day post-administration.
2725 mg/kg bw: 3/5 males died on Day 2 and 2/5 males died on Day 3 after administration of the test substance, respectively. All females died on Day 1 after administration of the test substance.

Clinical signs:

other: 109 mg/kg bw: no clinical signs occured in all animals. 545 mg/kg bw: tremor, convulsions and a decline in general conditions were observed in all males and females 10 min after administration of the test substance. These effects persisted in 3/5 males up

Gross pathology:

Necropsy was not performed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS Category 4, H302 according to Regulation (EC) No. 1272/2008.

Conclusions:

In an acute oral toxicity study with rats, performed similar to OECD 401, a LD50 of 959 mg/kg bw was determined.