Azelaic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Acute oral toxicity study with rats

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Decanoic acid

EC Number:

206-376-4

EC Name:

Decanoic acid

Cas Number:

334-48-5

IUPAC Name:

decanoic acid

Details on test material:

- Name of test material (as cited in study report): UDL-910
- Composition of test material, percentage of components: no further data given
- Analytical purity: no information given

Test animals

Species:

rat

Strain:

other: COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 187 - 322 g

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

ethanol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 5%

Doses:

10000, 14000, 16800, 19600 and 25000 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: prior to and at the end of study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

15 800 mg/kg bw

Based on:

test mat.

95% CL:

14 110 - 17 700

Mortality:

10000 mg/kg bw: no mortality
14000 mg/kg bw: 2/5males
16800 mg/kg bw: 3/5 males and 3/5 females
19600 mg/kg bw: 5/5 males and 5/5 females
25000 mg/kg bw: 5/5 males and 5/5 females

Clinical signs:

other: 10000 mg/kg bw: decrease of motor activity, accelerated breathing, loss of righting reflex and proneness for 4hours 14000 mg/kg bw: decrease of motor activity for 24 hours, accelerated breathing, loss of righting and corneal reflex and proneness for 4 hou

Gross pathology:

Surviving animals showed moderate congestion of the kidneys and adrenal glands with proliferation of the mucosal tissue of the stomach. At doses above 19600 mg/kg bw also hemolytic lesions in the stomach were observed.