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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:
26 May to 9 June 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
GLP study conducted according to OECD guideline with minor deviation: no certificate of analysis
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
No certificate of analysis
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
other: Sprague-Dawley OFA
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: IFFA-CREDO, l'Arbresle, France
- Age at study initiation: about 6 weeks
- Weight at study initiation: 196-207 g for males; 174-171 g for females
- Fasting period before study: overnight
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): UAR A04-10, Epinay sur Orge, France
- Acclimation period: at least 5 days
- Housed according to directive 86/609/EEC

IN-LIFE DATES: From: 26 May 1998 To: 9 June 1998

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No data
Doses:
2000 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: clinical observations at least once a day, bodyweights recorded just prior to dosing and at days 4, 8 and 15
- Necropsy of survivors performed: yes
Statistics:
None

Results and discussion

Preliminary study:
No data
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One female was found dead at day 2.
Clinical signs:
Piloerection and a decrease in motor activity and in muscular tonus were observed in all animals for the first 6 h after dosing. All effects were reversed at day 3.
Body weight:
Body weight increase was normal (see table 1).
Gross pathology:
In the female found dead, congestions in the lungs, liver, spleen and kidneys were observed. Stomach and intestines were bloated by gas. In the other animals, no particular finding was identified.
Other findings:
No data

Any other information on results incl. tables

Table 1: individual bodyweights in males and females

 

Individual bodyweights (g) in males

Weight gain Day 1-Day 15

Animal number

Day 1

Day 4

Day 8

Day 15

9325

198.7

219.7

269.9

319.9

121.2

9326

196.0

196.7

240.7

288.7

92.7

9327

206.4

243.3

286.2

338.0

131.6

9328

198.2

221.6

266.6

307.2

109.0

9329

203.6

239.4

286.5

330.9

127.3

Mean ± SD

200.6 ± 4.3

224.1 ± 18.6

270.0 ± 18.7

316.9 ± 19.6

116.4 ± 15.7

 

Individual bodyweights (g) in females

Weight gain Day 1-Day 15

Animal number

Day 1

Day 4

Day 8

Day 15

9330

180.9

197.7

214.5

243.3

62.4

9331

174.3

-

-

-

-

9332

174.7

195.9

219.8

246.2

71.5

9333

175.7

202.3

222.5

250.0

74.3

9334

175.7

196.5

226.8

245.7

70.0

Mean ± SD

176.3 ± 2.7

198.1 ± 2.9

220.9 ± 5.1

246.3 ± 2.8

69.6 ± 5.1

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of the test substance is higher than 2000 mg/kg bw for males and females. According to CLP regulation (EC) No 1272/2008, the test substance should not be classified.
Executive summary:

Acute oral toxicity study (limit test) with test substance Terpineol multiconstituent was conducted in 10 Sprague-Dawley OFA rats (5 males and 5 females) following OECD guideline 401. The test substance was administered undiluted through oral gavage at the single dose of 2000 mg/kg bw. Animals were observed for clinical signs at least once a day for 14 days. Body weights were taken just before dosing and at days 4, 8 and 15.

Piloerection and a decrease in motor activity and in muscular tonus were observed in all animals for the first 6 h after dosing. All effects were reversed at day 3 except for one female, found dead at day 2. In this female, congestions in the lungs, liver, spleen and kidneys were observed. Stomach and intestines were bloated by gas. In the other animals, no particular finding was identified at necropsy. Bodyweight increase throughout the study was normal.

The oral LD50 of the test substance is higher than 2000 mg/kg bw for males and females. Therefore, according to CLP regulation (EC) No 1272/2008, the test substance should not be classified.