Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Principles of method if other than guideline:
The test substance is applied orally by gavage in graduated doses to seven groups of cats, one dose being used per group.
Subsequently, observations of deathss and clinical effects including the determination of methemoglobin level in the blood are made.
GLP compliance:
no
Test type:
other: acute test
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Aniline
EC Number:
200-539-3
EC Name:
Aniline
Cas Number:
62-53-3
Molecular formula:
C6H7N
IUPAC Name:
aniline
Details on test material:
- Name of test material (as cited in study report): aniline
- Analytical purity: p. a.

Test animals

Species:
cat
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BASF AG, Department of Toxicology
- Weight at study initiation: 2.4 kg (male), 1.9 kg (female)
- Diet (e.g. ad libitum): A soft feed made of cooked oat flakes, Latz-Purin and sodium chloride; sometimes the meat of whales; ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous emulsion in traganth
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.05 - 1% aqueous emulsion in traganth
Doses:
1.0, 2.6, 5.1, 10.2, 25.6, 51.1 and 102.2 mg/kg
No. of animals per sex per dose:
2 animals per dose (two males, two females or one male and one female); in total 14 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 3 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, methaemoglobin formation

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
approximate LD50
Effect level:
>= 102 mg/kg bw

Any other information on results incl. tables

One out of two male cats died after administration of 102.2 mg/kg bw aniline. Light cyanosis was seen at day 1 after application of 2.6 mg/kg. Doses of 5.1, 10.2 and 25.6 mg/kg bw caused cyanosis in all animals. 51.1 mg/kg caused severe cyanosis with staggering gait, atony and vocalisation. In the high dose animals (102.2 mg/kg bw), severe cyanosis accompanied by accelerated breath and lateral position.

Animal

Haemoglobin [%]

Hours after administration

Dose [mg/kg]

Pre-test

2

4

6

24

30

48

72

102.2

1

0.5

74.1

71.2

79.9

28.2*

-

-

-

102.2

2

0.2

73.8

77.4

78.8

70.5

56.9

4.8

3.1

51.1

3

0

66.1

76.0

73.0

2.5

2.0

0

0

51.1

4

3.6

55.6

63.2

35.1

2.0

1.2

0.4

0.4

25.6

5

0

60.6

71.3

70.6

1.8

1.2

0.9

0

25.6

6

0

62.9

65.1

61.1

2.4

1.0

1.1

0

10.2

7

0

66.8

64.0

49.7

0.5

0.5

0.5

1.2

10.2

8

0

41.8

34.5

20.2

0.9

0.9

0.3

1.2

5.1

9

0

29.0

12.8

4.5

1.0

0.9

0

0.8

5.1

10

0

24.6

8.1

0

0.6

0

0

0

2.6

11

0

8.1

2.6

0.3

0

1.3

0.7

0.7

2.6

12

0.8

10.2

3.4

0

0.6

0

0

0

1.0

13

0.5

3.4

2.6

1.2

0.8

0

1.0

0

1.0

14

0.5

6.0

1.6

1.0

0.5

0

0

0

* Blood was taken after death.

Applicant's summary and conclusion