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Description of key information

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:
June 26, 1979 to July 2, 1979
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 17- 25.
Deviations:
not applicable
GLP compliance:
yes
Specific details on test material used for the study:
Ceraphy1 65, Batch # 6371
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were ordered from a suitably licensed dealer, in equal numbers of each sex
Bodyweight: between 200 and 250 grams ,
Age: approximately 6 to 8 weeks
Upon receipt, animals were carefully checked for respiratory difficulty, ocular or nasal lacrimation, dehydration, diarrhea, and general thriftiness.
Animals were acclimated for at least 2 days prior to test initiation.
Housing: in galvanized cages with indirect bedding, in a temperature controlled room with a 12 hour light/dark cycle.
Diet: consisted of a growth and maintenance ration from a commercial producer
Water: ad libitum.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
After approximately 18 hours of fasting, each rat was weighed and marked with an ear clip.
Individual doses, calculated on the basis of bodyweight, were adm inistcred using a stainless steel iintragastric feeding needle, of sufficient bore to allow even passage of the test article.
After dosing, the rats returned to their cages, with food and water available ad libitum.
Each cage was labelled uniquely with respect to job number, test article, dose level, sex, animal number(s), and date of dosing.
Doses:
5 grams per kilogram of bodyweight corresponding with ca. 3 g of Quaternium 26 per kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post dosage. Observations were made at least once daily thereafter for a total of 14 days.
Animals sacrificed at the end of the 14 day observation period, as well as nonsurvivors, were subjected to complete gross necropsy, with all findings noted.
Statistics:
The test article was considered to be orally toxic to rats at 5 grams per kilogram of bodyweight if 50% or more of the animals in the test group died during the 14-day observation period.
Sex:
male/female
Dose descriptor:
LD100
Remarks:
Reached after 2 days following dosing
Effect level:
5 000 mg/kg bw
Based on:
test mat. (total fraction)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 5 000 mg/kg bw
Based on:
test mat. (total fraction)
Sex:
male/female
Dose descriptor:
LD100
Effect level:
3 000 mg/kg bw
Based on:
test mat.
Remarks:
Quaternium 26
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 3 000 mg/kg bw
Based on:
test mat.
Remarks:
Quaternium 26
Mortality:
All rats died during the first two days following dosing.
Clinical signs:
No significant signs other than a slight depression were observed before the rats died.
Animal #1,#6-#10: Test article in stomach. No gross· changes observed.
Animal #2,#3,#5:Stomach and intestines distended and gas filled.
Animal #4:No gross changes observed.
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Study showed that the LD50 < 5000 mg/kg for the total fraction of Ceraphyl 65. There is no evidence that the LD50 is > 2000 mg/kg, thus additional testing is necessary for conclusive classification.
Conclusions:
The test article is toxic orally to rats under conditions of this test.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 12, 1979 to July 26, 1979
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
E.C. Hagan, "Acute Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 17- 25.
Deviations:
not applicable
GLP compliance:
yes
Specific details on test material used for the study:
3% Ceraphyl 65, w/w in Deionized Water Batch# 6371
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals were ordered from a suitably licensed dealer, in equal numbers of each sex
Bodyweight: 202-252 grams ,
Age: approximately 6 to 8 weeks
Upon receipt, animals were carefully checked for respiratory difficulty, ocular or nasal lacrimation, dehydration, diarrhea, and general thriftiness.
Animals were acclimated for at least 2 days prior to test initiation.
Housing: in galvanized cages with indirect bedding, in a temperature controlled room with a 12 hour light/dark cycle.
Diet: ad libitum and consisted of a growth and maintenance ration from a commercial producer
Water: ad libitum.
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
After approximately 18 hours of fasting, each rat was weighed and marked with an ear clip.
Individual doses, calculated on the basis of bodyweight, were adm inistcred using a stainless steel iintragastric feeding needle, of sufficient bore to allow even passage of the test article.
After dosing, the rats returned to their cages, with food and water available ad libitum.
Each cage was labelled uniquely with respect to job number, test article, dose level, sex, animal number(s), and date of dosing.
Doses:
20 ml of a 3% solution per kilogram of bodyweight corresponding with ca. 600 mg of Ceraphyl 65 per kg bw or of 360 mg Quaternium 26 per kg bw.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Animals were observed for signs of pharmacologic activity and drug toxicity at 1, 3, 6, and 24 hours post dosage. Observations were made at least once daily thereafter for a total of 14 days.
Animals sacrificed at the end of the 14 day observation period, as well as nonsurvivors, were subjected to complete gross necropsy, with all findings noted.
Statistics:
The test article was considered to be orally toxic to rats if 50% or more of the animals in the test group died during the 14-day observation period.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 600 mg/kg bw
Based on:
test mat. (total fraction)
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 360 mg/kg bw
Based on:
test mat.
Remarks:
Quaternium 26
Mortality:
One male rat was found dead at 24 h following dosing. All other rats survived the 14-day observation period.
Clinical signs:
No effects
Body weight:
No effects
Gross pathology:
Animal #1,#3-#7,#9,#10: No gross changes observed.
Animal #2: Test article in stomach: No gross changes observed.
Animal #8: Inferior lobe of right lung consolidated.
Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Study showed that the LD50 > 600 mg/kg for the total fraction of Ceraphyl 65. There is no evidence that the LD50 is > 2000 mg/kg, thus additional testing is necessary for conclusive classification.
Conclusions:
The test article is toxic orally to rats under conditions of this test.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
In-vivo studies with Ceraphyl 65 showed that the LD50 > 360 and < 3000 mg/kg for the substance under registration.

Additional information

Justification for classification or non-classification

In-vivo studies showed that the LD50 > 600 and < 5000 mg/kg for the total fraction of Ceraphyl 65. Supposing 60% of Fatty acids, mink, reaction products with 3-(dimethylamino)propylamine and 2-chloroethanol present in Ceraphyl 65, the LD50 is between 360 and 3000 mg/kg and there is no evidence that the LD50 is > 2000 mg/kg. Hence, the classification should be acute toxic cat. 4.