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Diss Factsheets

Administrative data

Description of key information

The acute oral toxicity for (+) CAMPHOLENIC ALDEHYDE was determined to be > 2000 mg/kg bw according to a study performed in agreement with OECD Guideline 401.
(-) CAMPHOLENIC ALDEHYDE is an isomer of (+) CAMPHOLENIC ALDEHYDE. Data on (+) CAMPHOLENIC ALDEHYDE can be extrapolated to (-) CAMPHOLENIC ALDEHYDE.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
(-) CAMPHOLENIC ALDEHYDE is an isomer of (+) CAMPHOLENIC ALDEHYDE. Data on (+) CAMPHOLENIC ALDEHYDE can be extrapolated to (-) CAMPHOLENIC ALDEHYDE.
Reason / purpose for cross-reference:
read-across source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: Just after the treatment, and during the first six hours following administration of the test substance, a slight piloerection was noticed in all animals with a decrease in motor activity and in muscle tone (staggering gait) appearing 1 hour after treatme
Gross pathology:
Gross necroscopy of animals 14 days after treatment did not show any visible organic or tissular lesions which may imply a possible systemic toxicity of the test substance.

Table 1: Individual animal bodyweights

 Animal number  D1  D4  D8  D15  D15 -D1
 Male               

 9285

 185.0  201.6  264.0  331.8  146.8
 9286  172.2  193.3  251.8  311.0  138.8
 9287  180.6  202.0  264.8  324.7  144.1
 9288  203.8  207.9  262.9  332.3  128.5
 9289  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               
 9290  182.2  184.5  215.7  233.2  51.0
 9291  187.6  199.5  238.3  264.8  77.2
 9292  190.8  203.2  227.4  259.3  68.5
 9293  180.8  189.4  235.9  258.6  77.8
 9294  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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the acute oral toxicity of the test substance was determined to be LD50 >2000 mg/kg bw.
Executive summary:

In a GLP compliant acute oral toxicity study conducted in line with standardised guideline OECD 401, the acute oral toxicity of the test substance was determined. Under the conditions of the test, the LD50 of the test substance in rats was determined to be >2000 mg/kg bw and so the substance is considered to be unclassified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study is GLP complaint and has Klimisch score of 1.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available
Quality of whole database:
Substance is an intermediate and only available data need to be submitted.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Oral

The key study was performed in line with GLP and a standardised guideline at a single dose of 2000 mg/kg. No mortality occurred during the study and so the LD50 for the test substance was set as >2000 mg/kg bw. The study was selected as the key study on the basis that it was performed in line with GLP and a standardised guideline.

Justification for classification or non-classification

Oral

According to Regulation (EC) No 1272/2008, the studies available suggest that the test substance is considered to be unclassified for acute oral toxicity.