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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 October 1987 to 25 November 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
OECD Guidelines for Testing of Chemicals (1981) No. 401 "Acute Oral Toxicity"
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Six male and six female Sprague-Dawley CFY strain rats were supplied by Interfauna (UK) Limited, Wyton, Huntingdon, Cambridgeshire. At the start of the main study the males weighed 124 - 139g, and the females 120 - 140g, and were approximately five to eight weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a unique number within the study by ear punching and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.
The animal room was maintained at a temperature of 19 – 22 °C and relative humidity of 45 - 65%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
For the purpose of the study the test material was ground to a fine powder using a mortar and pestle and freshly prepared, as required, as a solution/suspension at the appropriate concentration in arachis oil B.P.
Dose volume: 10 mL/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
Range finding study: 2 (1 male/1 female)
Main Study: 10 (5 male/5 female)
Control animals:
no
Details on study design:
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Animals were observed 1 and 4 hours after dosing and subsequently once daily for 14 days. Deaths and evidence of overt toxicity were recorded at each observation.
Individual bodyweights were recorded on the day of treatment (day 0), and on days 7 and 14.
All animals were subjected to gross necropsy examination for any macroscopic abnormalities. No tissues were retained.
Statistics:
Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made. Clinical observations, bodyweight and necropsy records were examined for any adverse but non-lethal effects resulting from treatment.

Results and discussion

Preliminary study:
No mortalities.
Using the mortality data given in the above table the oral LD50 of the test material was considered to be greater than 5000 mg/kg. This dose level was therefore used for the main study.
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
There were no signs of systemic toxicity during the study period.
Body weight:
All animals showed expected gains in bodyweight over the study period.
Gross pathology:
No abnormalities were detected at necropsy of animals killed at the end of the study.
Other findings:
Light blue-coloured staining of the general body hair was noted in all animals one to six days after treatment.

Any other information on results incl. tables

Mortality Data

The mortality data are summarised as follows:

DOSE LEVEL

mg/kg

SEX

DEATHS ON DAY:

TOTAL DEATHS

0

1

2

3

4

5

6

7

8-14

5000

MALE

0

0

0

0

0

0

0

0

0

0/10

FEMALE

0

0

0

0

0

0

0

0

0

 

INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA IN THE MAIN STUDY

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL

mg/kg

ANIMAL NUMBER & SEX

HOURS AFTER DOSING

DAYS AFTER DOSING

1

4

1

2

3

4

5

6

7

9

8

10

11

12

13

14

5000

3-0

MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

3-1

MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

3-2

MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

3-3

MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

3-4

MALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

4-0

FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

4-1

FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

4-2

FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

4-3

FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

4-4

FEMALE

0

0

0

St

0

St

0

St

0

St

0

St

0

St

0

0

0

0

0

0

0

0

St = light blue-coloured staining of the general body hair                         0 = no systemic toxicity detected

 

INDIVIDUAL BODYWEIGHTS AND WEEKLY BODYWEIGHT INCREASES IN THE MAIN STUDY

TEST MATERIAL: DISPERSIONSBLAU F-60 768

DOSE LEVEL

mg/kg

ANIMAL NUMBER & SEX

BODYWEIGHT (g) AT DAY

INCREMENT (g) DURING WEEK

0

7

14

1

2

5000

3-0

MALE

126

195

245

69

50

3-1

MALE

128

198

260

70

62

3-2

MALE

139

216

274

77

58

3-3

MALE

136

206

265

70

59

3-4

MALE

124

185

244

61

59

4-0

FEMALE

120

170

192

50

22

4-1

FEMALE

126

180

202

54

22

4-2

FEMALE

130

194

234

64

40

4-3

FEMALE

124

190

228

66

38

4-4

FEMALE

140

211

235

71

24

 

INDIVIDUAL NECROPSY FINDINGS IN THE MAIN STUDY

TEST MATERIAL: DISPERSIOSBLAU F-60 768

DOSE LEVEL

mg/kg

ANIMAL NUMBER & SEX

MACROSCOPIC OBSERVATIONS

5000

3-0

MALE

Killed day 14

No abnormalities detected

3-1

MALE

Killed day 14

No abnormalities detected

3-2

MALE

Killed day 14

No abnormalities detected

3-3

MALE

Killed day 14

No abnormalities detected

3-4

MALE

Killed day 14

No abnormalities detected

4-0

FEMALE

Killed day 14

No abnormalities detected

4-1

FEMALE

Killed day 14

No abnormalities detected

4-2

FEMALE

Killed day 14

No abnormalities detected

4-3

FEMALE

Killed day 14

No abnormalities detected

4-4

FEMALE

Killed day 14

No abnormalities detected

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of the test material, Dispersionsblau F 60 768 to the rat was found to be greater than 5000 mg/kg bw.
The substance is not classifiable according to CLP criteria.
Executive summary:

A study was performed to determine the acute oral median lethal dose (LD50) of the test material, administered as a solution/suspension in arachis oil B.P., in the Sprague-Dawley CFY strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 401 “Acute Oral Toxicity”.

 

Following a range-finding study, a single group of ten fasted animals (five males and five females), was given a single oral dose of test material preparation at a dose level of 5000 mg/kg bodyweight.

 

There were no deaths. No signs of systemic toxicity were noted during the study period. All animals showed light blue-coloured staining of the general body hair one to six days after treatment.

 

All animals showed expected gains in bodyweight over the study period.

 

No abnormalities were noted at necropsy of animals killed at the end of the study.

 

The acute oral median lethal dose (LD50) of the test material, DISPERSIONSBLAU F-60 768, to the rat was found to be greater than 5000 mg/kg bodyweight.

The substance is not classified according to CLP criteria.