Dibenzylamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

other: Acute oral toxicity study in male and female Wistar-rats

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dibenzylamine

EC Number:

203-117-7

EC Name:

Dibenzylamine

Cas Number:

103-49-1

Molecular formula:

C14H15N

IUPAC Name:

dibenzylamine

Details on test material:

purity: 99.1%

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
- Age at study initiation: male: 6-7 weeks; female 8-9 weeks
- Weight at study initiation: male 183 g, female 162 g
- Fasting period before study: 16 h
- Housing:
- Diet ad libitum
- Water ad libitum
- Acclimation period:

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

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

single oral application by gavage of test substance diluted in polyethylene glycol

Doses:

200 mg/kg bw
2000 mg/kg bw (administered only to female rats)

No. of animals per sex per dose:

200 mg/kg bw (5 male and 5 female rats)
2000 mg/kg bw (5 female rats )

Control animals:

not specified

Details on study design:

males were not fed with 2000 mg/kg bw because all females died;
observation for clinical signs and mortality for up to 14 days, body weight determination on day 1, and at the end of the observation period;
pathological-anatomical evaluation after termination of the study

Statistics:

calculation of LD50- value according to Spearman - Kärber, or if only 1 dose used. estimation of the LD50-value

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 632 mg/kg bw

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Mortality:

male : 0/5 (200 mg/kg bw)
female: 0/5 (200 mg/kg bw)
female 5/5 (2000 mg/kg bw)

Clinical signs:

other: 200 mg/kg bw was tolerated without clincal symptoms from male amd female rats 2000 mg/kg bw: 15 min post dosing animals suffered from "spasmic-jumping behaviour" ; 20 min post application all female rats died

Gross pathology:

2000 mg/kg bw, female: stomach filled with yellowish liquid, reddened mucous membranes of the stomach, and the lungs
200 mg/kg bw, males and females were without gross pathological findings

Any other information on results incl. tables

Sex	Dose (mg/kg bw)	No. of animals (mortalities/animals used)	Timepint of death	Mortality (%)
male	200	0/5	-	0
female	200	0/5	-	0
female	2000	5/5	20 minutes	100

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The approximately LD50 value for female rats was 632 mg/kg bw and the LD50 value for male rats was >200 mg/kg bw (Bayer AG.1995)

Executive summary:

Single oral application of 200 mg/kg bw diluted in polyethylene glycole was given to male and female Wistar rats by gavage. Since all females that received 2000 mg/kg bw, died, no males were tested with this dose. Signs of intoxication before death were "spasmic-jumping behaviour" ; 200 mg/kg bw was tolerated by males and females without symptoms. Body weight development was not influenced at the dose of 200 mg/kg bw in both sexes. Post mortem exanination was without findings in 200 mg/kg bw males and females but females that had received 2000 mg/kg bw, showed yellow fluid in the stomach and reddened mucosa in stomach and lungs.The approximately LD50 value for female rats was 632 mg/kg bw and the LD50 value for male rats was >200 mg/kg bw (Bayer AG.1995)