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Description of key information

LD50 oral rats > 10ml/kg (similar to OECD 401)

LD50 dermal rabbits > 5000mg/kg (based on the worst case of a one-to-one read across and confirmed by an OECD QSAR Toolbox prediction)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight.
After treatment the rats received stock diet and tap water as libitum.
They were observed for signs of intication during 14 day period, after which autopsies were carried out on the survivors.
GLP compliance:
not specified
Test type:
acute toxic class method
Specific details on test material used for the study:
A 50 ml sample of the test material was received from the principal in January 1978. It was a colourless liquid with a pugent odour, designated Sinodor 688 and coded M-76-193.
Species:
rat
Strain:
Wistar
Remarks:
Young adult albino rats (wistar-derived)
Sex:
male/female
Details on test animals or test system and environmental conditions:
Young adult albino rats (Wistar-derived) from the Institue's colony were used. The body weights of males varied from 209 to 248g, those of females from 145 to 186g. The rats were housed in groups of five in screen-bottomed stainless steel cages, in a well-ventilated room, maintained at 23-25°C. Before dosing the rats were fasted overnight.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight.
Doses:
10.0 ml per kg body weight
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
After some preliminary observations, the test material was given undiluted, by gavage to groups of five males and five females, in one single dose of 10.0 ml per kg body weight. Due to the small quantity of the test material, no higher doses could be given. After treatment the rats received stock diet and tap water ad libitum. They were observed for signs of intoxication during a 14 day period, after which autopsies were carried out on the survivors.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No deaths
Mortality:
No deaths occured
Clinical signs:
other: Within a few hours after dosing the rats showed signs of sluggishness and decreased activity. Later on the rats recovered and looked quite healthy during the remaining part of the observation period. Macroscopic examination of the survivors at autopsy r
Interpretation of results:
GHS criteria not met
Conclusions:
From these results it appears that the oral LD50 of Sinodor exceeds 10 ml per kg body weight.
Executive summary:

Acute oral toxicity was determined with a method similar to OECD Guideline 401.

At a dose of 10 ml/kg body weight, no deaths occured and clinical signs a few hours after dosing were that the rats showed signs of sluggishness and decreased activity.

Later on the rats recovered and looked quite healthy during the remaining part of the observation period. Macroscopic examination of the survivors at autopsy revealed no treatment related gross alterations.

From these results it appears that the oral LD50 of Sinodor exceeds 10 ml per kg body weight, GHS criteria not met.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
A detailed read-across justification in-line with the ECHA RAAF guidelines is provided as an attached document.
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured
Clinical signs:
other: Symptomatology: none
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 dermal in rats expected to be above 5000 mg/kg.
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
5 g/kg
No. of animals per sex per dose:
10 animals (sex not specified)
Control animals:
no
Details on study design:
Not specified
Key result
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured
Clinical signs:
other: Symptomatology: none
Interpretation of results:
GHS criteria not met
Conclusions:
Based on this study, acute dermal LD50 for Citronellyl crotonate is > 5 000 mg/kg. No classification required.
Executive summary:

Ten rabbits were administered 5 g/kg of the test material, and the animals were observed for mortality and clinical signs for 14 days. No deaths or effects observed so acute dermal LD50 > 5g/kg. No classification required.

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

Additional information

Acute Oral Toxicity Study:

Acute oral toxicity was determined with a method similar to OECD Guideline 401.

At a dose of 10 ml/kg body weight, no deaths occured and clinical signs a few hours after dosing were that the rats showed signs of sluggishness and decreased activity.

Later on the rats recovered and looked quite healthy during the remaining part of the observation period. Macroscopic examination of the survivors at autopsy revealed no treatment related gross alterations.

From these results it appears that the oral LD50 of Sinodor exceeds 10 ml per kg body weight, GHS criteria not met.

Acute Dermal Toxicity Study:

Ten rabbits were administered 5 g/kg of the test material, and the animals were observed for mortality and clinical signs for 14 days. No deaths or effects observed so acute dermal LD50 > 5g/kg. No classification required.

An OECD QSAR Toolbox analysis was performed for this endpoint and predicted an LD50 above 10g/kg, confirming the above selected one-to-one read-across.

Justification for classification or non-classification

Based on the data available and key results described in this summary, the substance has shown no acute systemic toxicity potential and should therefore not be classified for acute toxicity according to the (EC) No 1272/2008 Regulation (CLP).