Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine

Endpoint summary

Description of key information

Acute toxicity: oral
A K1 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Gabriel, 1995). 
The acute oral LD50 value in male/female Sprague-Dawley rats was >2000 mg/kg bw.
Acute toxicity: inhalation
A K2 acute inhalation toxicity test was performed in male Sprague Dawley rats according to a guideline similar to OECD Guideline 403 (Gabriel, 1974). 
The acute oral 1-hr LC50 value in male Sprague-Dawley rats was 3.1 mg/L.
Acute toxicity: dermal
A K2 acute dermal toxicity test was performed in New Zealand whithe rabbit following the OECD 402 Guideline (Gabriel, 1974). 
The acute dermal LD50 value rabbits is > 8000 mg/kg bw.
Acute toxicity: other routes
No reliable studies were available for this endpoint.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

3 100 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute toxicity: oral:

Gabriel (1995) performed an acute oral toxicity study (gavage) in Sprague-Dawley rats similar to the OECD 401 test guideline. After exposure to a single dosis, all animals (5 in total) were observed for 14 days. An LD50 value of > 2000 mg/kg bw was determined for male and female rats.

Acute toxicity inhalation:

Gabriel (1974) performed an acute inhalation toxicity study (1 hour whole body exposure, air as vehicle) in male albino rats according to a guideline similar to OECD Guideline 403. From the results obtained in this study, it appears that the substance would be considered to be toxic but not highly toxic by the inhalation route of administration since the LC50 is approximately 3.1 mg/liter.

Acute toxicity: dermal:

Gabriel (1974) performed an acute dermal toxicity study in New Zealand White rabbit according to OECD Guideline 402. After exposure to a single dose of either 1000, 2000, 4000 or 8000 mg/kg, all animals (4 per sex and per dose) were observed for 14 days. An LD50 value of ca. 8000 mg/kg bw was observed.

Acute toxicity: other routes:

No reliable studies were available for this endpoint.

Justification for selection of acute toxicity – oral endpoint
Only one reliable study available

Justification for selection of acute toxicity – inhalation endpoint
Only one reliable study available

Justification for selection of acute toxicity – dermal endpoint
Only one reliable study available

Justification for classification or non-classification

Based on the available data and according to the DSD and CLP criteria the substance should be classified as R23 and for acute inhalation toxicity category 3.

Based on the available data and according to the DSD and CLP criteria the substance should not be classified for acute oral and dermal toxicity.