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Diss Factsheets

Administrative data

Description of key information

In an acute oral toxicity study with rats, performed equivalent to OECD 401 guidelines, an LD50 of 7.73 mL/kg bw was determined. In a supporting acute oral toxicity study with rats, performed equivalent to OECD 401 guideline, an LD50 >5000 mg/kg bw was determined.

Therefore no classification is required for acute oral Toxicity.

In an acute dermal toxicity study with rabbits, performed equivalent to OECD 402 guideline, an LD50 >5000 mg/kg bw was determined.

Therefore no classification is required for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 13, 1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 401). Non GLP. Deviations: no details on test material, limited details on test animals and environmental conditions. However, dose, number of animals and observation period and considering mortality observed, the result is considered reliable with restrictions.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
no details on test material, limited details on test animals and environmental conditions.
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): Compound A - 7155 (1-Formyl1-Methyl-4-(4methyl-dentan-1-yl)-Cyclohexane)
- Description: colorless liquid

Please note that although the substance is stated as a mono-constituent substance 21-Formyl1-Methyl-4-(4methyl-dentan-1-yl)-Cyclohexane in the report, recent analytical data had been determined the substance to be a multi-constituent (Reaction mass of 1-methyl-3-(4-methylpentyl)-3-cyclohexene-1-carboxaldehyde and 1-methyl-4-(4-methylpentyl)-3-cyclohexene-1-carboxaldehyde). As the chemical manufacturing process has not changed since the report was written, the recent analytical information is relevant to the batch which was tested.
Species:
rat
Strain:
other: Holtzman
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 100 to 125 g
- Housing: in raised wire mesh cages
- Diet: regular diet of Fox Blox

Route of administration:
other: intragastrically (gavage)
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
GAVAGE METHOD: rigid stomach tube, single dose.

MAXIMUM DOSE VOLUME APPLIED: 8.0 mL/kg) body weight

Doses:
1.0, 1.3, 6.0, 6.2, 6.5, 7.0, 7.5 and 8.0 mL/kg body weight. We assume dose 1.0 and 1.3 should read 10 and 13 mL/kg considering the results.


No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Clinical signs for observation: loss in body weight, convulsions, ataxia, emesis and or death
- Necropsy of survivors performed: no
Statistics:
The method of Litchfield, V.T. and Wilcoxon, F., Journal of Pharmacology and Experimental Therapeutics, Vol/ 96, p.99, 1949 was used in calculating the oral LD50.
Sex:
female
Dose descriptor:
LD50
Effect level:
7.73 mL/kg bw
Based on:
test mat.
95% CL:
7 - 8.5
Mortality:
6.0 mL/kg: 0/10
6.2 mL/kg: 1/10
6.5 mL/kg: 3/10
7.0 mL/kg: 3/10
7.5 mL/kg: 4/10
8.0 mL/kg: 6/10
10 mL/kg: 8/10
13 mL/kg: 10/10
Clinical signs:
other: Not reported.
Gross pathology:
No data
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study with rats, performed equivalent to OECD 401 guidelines, an LD50 of 7.73 mL/kg bw was determined.
Executive summary:

Compound A - 7155 (1-Formyl1-Methyl-4-(4methyl-dentan-1-yl)-Cyclohexane) was tested in an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline. Deaths occurred starting at the 6.2 mL/kg dose level.

Based on the results, an LD50 of 7.73 mL/kg bodyweight was determined.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
October, 1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 401). Non GLP. Deviations: lack of study design details in the report, no details on test material, no details on test animals and environmental conditions. Only a very short description is reported. However, dose, number of animals and observation period and considering mortality observed, the result is considered reliable with restrictions.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
lack of study design details in the report, no details on test material, no details on test animals and environmental conditions.
GLP compliance:
no
Remarks:
not present at the time of performance.
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 77-449, Vernaldehyde
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
5000 mg/kg body weight.
No. of animals per sex per dose:
10 (in total)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: at least 6 observation days

Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
One animal died on day 6.
Clinical signs:
other: Diarrhea, slight lethargy, ptosis.
Gross pathology:
The following observations were observed:
Intestines yellow areas (1 animal), intestines bloated (1 animal), stomach yellow areas (1 animal), liver mottled (1 animal), lungs dark areas (7 animals), dark kidney (2 animals), pale kidney (1 animal) and dark spleen (1 animal).
Interpretation of results:
GHS criteria not met
Conclusions:
In an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline, an LD50 >5000 mg/kg bw was determined.
Executive summary:

Vernaldehyde was tested in an acute oral toxicity study with rats, performed equivalent to OECD 401 guideline. One out of ten animals died. Clinical signs were diarrhea, slight lethargy and ptosis. The following necropsy observations were observed:

Intestines yellow areas, intestines bloated, stomach yellow areas, liver mottled, lungs dark areas, dark kidney, pale kidney and dark spleen. Based on the results, an LD50 >5000 mg/kg bodyweight was determined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
7 730 mg/kg bw

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October, 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study meets the EC Standards (conducted equivalent to OECD 402). Non GLP. Deviations: lack of study design details in the report, no details on test material, limited details on test animals and environmental conditions. Only a very short description is reported. However, dose, number of animals and observation period and considering mortality observed, the result is considered reliable with restrictions.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
lack of study design details in the report, no details on test material, limited details on test animals and environmental conditions.
GLP compliance:
no
Remarks:
not present at the time of performance
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 77-449, Vernaldehyde
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
No data

ENVIRONMENTAL CONDITIONS
No data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
5000 mg/kg


No. of animals per sex per dose:
10 (in total)
Control animals:
not required
Details on study design:
No data
Statistics:
None.
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
other: None observed.
Gross pathology:
The following observations were observed:
Dark liver (3 animals), liver mottled (1 animal), pale kidney (1 animal) and exudate anogenital (1 animal).
Other findings:
All 10 animals showed severe redness and moderate edema.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an acute dermal toxicity study with rabbits, performed equivalent to OECD 402 guideline, an LD50 >5000 mg/kg bw was determined.
Executive summary:

Vernaldehyde was tested in an acute dermal toxicity study with rabbits, performed equivalent to OECD 402 guideline. No deaths occurred. The following necropsy observations were observed: Dark liver, liver mottled, pale kidney and exudate anogenital. All animals showed severe redness and moderate edema. Based on the results, an LD50 >5000 mg/kg bodyweight was determined.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Justification for classification or non-classification