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Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study following OECD guideline 401 well conducted but there was no certificate of analysis, no details about test substance and environmental conditions for animals
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no certificate of analysis, no details about test substance and environmental conditions
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: IFFA- CREDO (69210 - L'Arbresle, France)
- Age at study initiation: about 6 weeks
- Weight at study initiation: between 172 and 204 g for males, and 172 - 191 g for females? at the beginning of the study
- Fasting period before study: the night prior testing
- Housing: 5 animals by sex in polypropylenes cages (310 x 465 x 190)
- Diet (e.g. ad libitum): complete pelleted rat maintenance diet UAR A04-10 (91360 Epinay sur Orge - FRANCE), ad libitum
- Water (e.g. ad libitum):
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): not data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: May 26, 1998 To: June 09, 1998
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
single dose oF 2000 mg/kg of the test item
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for 14 days and one hour after dosing. Bodyweights were taken just prior to the test material administration (D1) and again on days 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology
Statistics:
n.a
Preliminary study:
n.a
Mortality:
no mortality
Clinical signs:
Just after the treatment and during the six first hours following administration of the test item, a slight piloerection was noticed in all the animals with, in the female # 9, a decrease in motor activity and in muscle tone (staggering gait) that appeared 1 hour after the treatment. The next day (D2), no modification in the aspect, behaviour or vegetative functions was observed in the animals. The other daily examinations which were repeated till the end of the observation period, failed to reveal any alteration in the general appearance and behaviour of the animals.
Body weight:
The individual growth weight of all the animals (males and females) was normal and regular. The mean weight gain 14 days after the treatment appeared satisfactory for this animal species.
Gross pathology:
The growth necropsy of the animals 14 days after dosing did not show any visible organic or tissular lesions leading to suspect a possible systemic toxicity of the product.

Body Weight – Individual values (g)

Male

Animals #

D1

D4

D8

D15

D15 – D1

1

185.0

201.6

264.0

331.8

146.8

2

172.2

193.3

251.8

311.0

138.8

3

180.6

202.0

264.8

324.7

144.1

4

203.8

207.9

262.9

332.3

128.5

5

178.4

192.3

255.4

307.7

129.3

Mean

184.0

199.4

259.8

321.5

137.5

SD

12.0

6.5

5.8

11.6

8.4

Female

 

Animals #

D1

D4

D8

D15

D15 – D1

1

182.2

184.5

215.7

233.2

51.0

2

187.6

199.5

238.3

264.8

77.2

3

190.8

203.2

227.4

259.3

68.5

4

180.8

189.4

235.9

258.6

77.8

5

172.0

189.9

221.6

238.4

66.4

Mean

182.7

193.3

227.8

250.9

68.2

SD

7.2

7.8

9.5

14.1

10.9

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not classified according to the criteria of Annex VI to the directive 67/548/EEC and CLP regulation (EC) n° 1272/2008.
Executive summary:

An acute oral toxicity study (limit test) with test substance (+) Campholenic Aldehyde was conducted in 10 albino Sprague Dawley rats (5/sex/dose) under GLP conditions following OECD guideline 401. The test substance was administered through oral gavage at the single dose of 2000 mg/kg bw. Animals were observed daily for clinical signs and mortality for 14 days. Body weights were taken prior to the administration of the test material, D4, D8 and D15. Six hours following administration of the test substance, a slight piloerection was observed in all animals with in the female #9, a decrease in motor activity and in muscle tone (staggering gait) that appeared 1 hour after the treatment. The next day (D2) and the following, no modification in the aspect, behaviour or vegetative functions was observed in the animals. There was no mortality. All animals were subjected to necropsy at the end of the observation period. No gross lesions were found.

Under the test conditions, oral LD50 of the test substance is higher than 2000 mg/kg bw. According to the criteria of Annex VI to the directive 67/548/EEC and CLP regulation (EC) n° 1272/2008, the test substance should not be classified for acute oral toxicity hazard.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Read-across performed with the other enantiomer form: (+) Campholenic Aldehyde.

There is no reason to believe that those two enantiomers have different behaviours regarding oral acute toxicity.


Justification for selection of acute toxicity – oral endpoint
Study well conducted and the only one available.

Justification for classification or non-classification

Under the test conditions, oral LD50 of the substance Campholenic Aldehyde (+) is higher than 2000 mg/kg bw. According to the criteria of CLP regulation (EC) n° 1272/2008, the test substance should not be classified for acute oral toxicity hazard. A read across is performed and thus Campholenic Aldehyde (-) should not be classified for acute oral toxicity.