Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
The aim of this study was to assess the toxicity potential of Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5) after single oral administration in Rats and an observation period of 14 days
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Species:Rattus norvegicus (Rat)Strain:Wistar Number and Sex:Twelve FemalesSupplier / Source: In-house animals, bred at Animal House.Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.Body weight of animals:Minimum: 136 g Maximum: 160 g (Individual body weights were within ± 20 % prior to treatment after overnight fasting)Age: 8 - 12 weeks at the time of dosing.Acclimatisation:Animal nos. 1-3 was acclimatized for 6 days, 4-6 for 10 days, 7-9 for 13 days and 10-12 for 6 days prior to administration of the test item. Identification:The animals were marked temporarily on tail, permanently on toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number, experimental start and completion date.Husbandry ConditionsDiet:All animals were provided conventional laboratory rodent dietBedding:All cages were provided with corn cobs Water: Aqua guard filtered tap water was provided ad libitum via drinking bottles.Husbandry:Group of three animals were housed in polycarbonate cages.Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day. Cages and water bottle:All the cages and water bottles were changed at least twice every week.Experimental Room ConditionTemperature:Minimum: 20.40 °C Maximum: 22.40 °CRelative humidity:Minimum: 49.10% Maximum: 67.30%Light-dark-rhythm: 12 hour light and 12 hour darkAir Changes: More than 12 changes per hour

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
VEHICLECorn oil was selected as a vehicle based on solubility testing.
Doses:
300 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
300 mg/kg bw -6 female rats2000 mg/kg bw-6 female rats
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: daily- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, mortality, body weight, pathology

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Non toxic
Mortality:
No mortality was observed in animals treated with 300 and 2000 mg/kg body weight throughout the 14 days observation period.
Clinical signs:
At 300 and 2000 mg/kg body weight, all the animals were observed normal throughout the experimental period.
Body weight:
Mean body weight of all the animals treated with 300 and 2000 mg/kg body weight were observed with gain on day 7 and 14, as compared to day 0
Gross pathology:
During external and internal gross pathological examination, terminally sacrificed animals treated with 300 and 2000 mg/kg body weight were observed with no abnormalities.

Any other information on results incl. tables

Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)

 

Sex:Female

 

Animal No.

Group/ Dose (mg/kg body weight)

 

Body Weight (gram)

Body Weight Change (%)

Dose Volume*

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

1

G1/ 300

1.5

149

182

197

22.15

32.21

2

1.4

136

174

190

27.94

39.71

3

1.6

158

194

206

22.78

30.38

4

1.4

142

182

201

28.17

41.55

5

1.4

142

180

191

26.76

34.51

6

1.5

152

191

197

25.66

29.61

7

G2/ 2000

1.5

152

189

191

24.34

25.66

8

1.4

142

168

180

18.31

26.76

9

1.6

156

186

200

19.23

28.21

10

1.5

154

226

238

46.75

54.55

11

1.6

155

218

229

40.65

47.74

12

1.6

160

233

242

45.63

51.25

*= Dose volume calculated based on day 0 body weight

 

Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)

 Sex:Female

Group/ Dose (mg/kg body weight)

Rats Body Weight (g)

Body Weight Changes (%)

Day 0

Day 7

Day 14

0-7

0-14

G1/ 300

Mean

146.50

183.83

197.00

25.58

34.66

SD

7.99

7.39

6.03

2.58

4.96

n

6

6

6

6

6

G2/ 2000

Mean

153.17

203.33

213.33

32.48

39.03

SD

6.08

25.94

26.32

13.31

13.51

n

6

6

6

6

6

Keys:SD = Standard Deviation, n = Number of Animals

 

Table 3: Individual Animal Clinical Signs and Symptoms

Sex:Female

Animal No.

Group/ Dose (mg/kg body weight)

Hours (Day 0)

1/2

1

2

3

4

1

G1/ 300

1

1

1

1

1

2

1

1

1

1

1

3

1

1

1

1

1

4

1

1

1

1

1

5

1

1

1

1

1

6

1

1

1

1

1

7

G2/ 2000

1

1

1

1

1

8

1

1

1

1

1

9

1

1

1

1

1

10

1

1

1

1

1

11

1

1

1

1

1

12

1

1

1

1

1

Key: 1 = Normal

Table 4: Individual Animal Mortality Record

 

Sex:Female

Animal No.

Group/ Dose (mg/kg body weight)

Day of Observation (Day 0 to 14)

Morning Observation

Evening Observation

1

G1/ 300

No mortality and morbidity

No mortality and morbidity

2

No mortality and morbidity

No mortality and morbidity

3

No mortality and morbidity

No mortality and morbidity

4

No mortality and morbidity

No mortality and morbidity

5

No mortality and morbidity

No mortality and morbidity

6

No mortality and morbidity

No mortality and morbidity

7

G2/ 2000

No mortality and morbidity

No mortality and morbidity

8

No mortality and morbidity

No mortality and morbidity

9

No mortality and morbidity

No mortality and morbidity

10

No mortality and morbidity

No mortality and morbidity

11

No mortality and morbidity

No mortality and morbidity

12

No mortality and morbidity

No mortality and morbidity


Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 (Cut-off value) of Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene (CAS No. – 37330-39-5) was 5000 mg/kg body weight.
Executive summary:

Acute Oral Toxicity was studied of Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  (CAS No. – 37330-39-5) in Rats.

Three rats of the first group G1 were dosed with starting dose of 300 mg/kg body weight and the animals did not show any mortality. So another three animals of the same group G1 were dosed with 300 mg/kg body weight and no mortality was observed. Next, three animals of group G2 were dosed with 2000 mg/kg body weight and no mortality was observed.

Under the conditions of this; and based on the examinations performed, acute oral toxicity study of Reaction mass of Cardanol diene and Cardanol monoene and Cardanol triene  (CAS No. – 37330-39-5)in female rats is as given below:

The acute oral LD50(Cut-off value) of Cardanol (CAS No. – 37330-39-5) was 5000 mg/kgbody weight.