Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987-05-23 to 1987-08-21
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
A modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration, was followed.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylanthraquinone
EC Number:
201-535-4
EC Name:
2-ethylanthraquinone
Cas Number:
84-51-5
Molecular formula:
C16H12O2
IUPAC Name:
2-ethyl-9,10-anthraquinone
Details on test material:
- Name of test material (as cited in study report): EAQ C8718-85
- Physical state: Not reported
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported

Test animals

Species:
rabbit
Strain:
other: albino rabbits
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Summit View Farm, Belvidere, New Jersey
- Age at study initiation: not reported
- Weight at study initiation: not reported
- Housing: not reported
- Diet (e.g. ad libitum): ad libitum (Wayne animal feeds)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes (duration not reported)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- Type of wrap if used: occluded patch (sleeve of plasticized material)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, gently cleansed
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 g/kg
- For solids, paste formed: no
Duration of exposure:
24 hours
Doses:
20 g/kg
No. of animals per sex per dose:
3 male, 3 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 3, 6, 24 hours after application, 2, 3, 4, 5, 6, 7, 14 days after application
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
The skins were pliable and non-irritated in all animals. One animal showed a slight depression on day 7 after treatment. No other abnormalities were observed.
Body weight:
All animals gained weight during the study.
Gross pathology:
No gross internal changes observed in any rabbit.

Any other information on results incl. tables

Acute Dermal Toxicity in Rabbits

Dose [g/kg]

Animal number and Sex

Bodyweight [kg]

Hours:

Days:

Bodyweight [kg]

1

3

6

24

2

3

4

5

6

7

14

20.0

1 Ma

1.66

N

N

N

N

N

N

N

N

N

N

N

1.85

2 M

1.50

N

N

N

N

N

N

N

N

N

N

N

1.64

3 Ma

3.18

N

N

N

N

N

N

N

N

N

N

N

3.51

4 F

2.77

N

N

N

N

N

N

N

N

N

N

N

2.84

5 Fa

2.66

N

N

N

N

N

N

N

N

N

N

N

2.79

6 F

1.65

N

N

N

N

N

N

N

N

N

SD

N

1.89

a = abraded skin

N = Normal

D = Depression

SD =Slight Depression

XD = Severe Depression

+ = Animal Death

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test substance is greater than 20 g/kg. The substance is therefore not classified for acute dermal toxicity according to Regulation (EC) No 1272/2008 (CLP).
Executive summary:

The acute dermal toxicity of the test item 2 -ethylanthraquinone was assessed.

A single application of 20 g/kg (test substance used as received) was given to 3 male and 3 female under an occluded patch. After 24 hours, the treated skin sites were gently cleansed. All animals were then observed for mortality, skin response and general behaviour for 14 days subsequent to exposure to the test material. One animal showed a slight depression on day 7 after treatment. No other abnormalities were observed.

The LD50 of the substance is greater than 20 g/kg. The substance is therefore not classified for acute dermal toxicity according to Regulation (EC) No 1272/2008 (CLP).