Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia

Endpoint summary

Description of key information

Oral: 
- acute toxicity, oral, rat, OECD 401, LD50 (female/male) > 2000 mg/kg bw (Henkel, BASF PCN, 1990) (50% A.I.)
- acute toxicity, dermal, rat, OECD 402, LD50 (female/male) > 4000 mg/kg bw (BASF11A0774/11X427) (50% A.I.)
Inhalation:
- No information on acute inhalation available for Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 000 mg/kg bw

Additional information

There are valid study data available assessing the acute oral and dermal toxicity of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia. No valid information for Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia on inhalation toxicity is available.

Oral:

OECD conform studies:

The acute oral toxicity of DHW 80 50% was tested according to OECD Guideline 401 (1987) in young Wistar rats (Henkel, BASF PCN 1990). The test article was dissolved in aqua dest. and given once orally by means of a stomach tube in a dose of 2000 mg/kg body weight to 5 male and 5 female animals. At frequent intervals at the day of application and twice a day at the following 14 days, the rats were observed for any sign of reactions. The surviving rats were sacrificed at the end of the observation period and a macroscopic postmortem examination was performed on all rats.

The LD50 of DHW 80 50% was >2000 mg/kg for male and female rats.

Dermal:

In an acute dermal toxicity study (Limit Test, according to OECD 402) , young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 4000 mg/kg bw of the test item Octadecanoic acid, 9,10-dihydroxy-, monoammoniumsalt (50% active substance in water) to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.

· No mortality occurred

· No signs of systemic toxicity or skin effects were observed

· The mean body weight of the male animals increased within the normal range throughout the study period.

· The mean body weight of the female animals did not significantly change during the first post-exposure week, probably due to the bandage procedure, but the animals gained weight in a normal range in the second week.

· No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study

Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 4000 mg/kg bw (>2000 mg/kg bw active ingredient)

Key study assignment:

As there is only one relevant and reliable study available assessing each the oral and the dermal toxicity and both were well performed and documented according to OECD guidelines and under GLP, these study were included as key studies.

No acute inhalation study available is available. These studies were not proposed or conducted because exposure consideration point to a more likely dermal exposure.

Assessment of acute toxicity:

Oral: The only available animal study points to high acute oral toxicity, LD 50 > 2000 mg/kg bw for DHW 80 (50%) (expected to be above 2000 mg/kg bw for AS 100%). Additional a 90 day repeated dose (HENKEL/COGNIS.R9400320, 1995) and a OECD 421 (BASF.80R0774/11X309, 2013) study shows no adverse effects up the highest tested dosage of 1000 mg/kg bw/day DHW80 (compareable to 500mg/kg bw/day active ingredient). Therefore a no acute toxicity is assumed and no classification is derived.

Dermal: The only available dermal acute toxicity study reveals no effects at the highest tested dosage LD 50 > 4000 mg/kg bw DHW 80 (50%) (>2000 mg/kg bw active ingredient. Therefore no acute dermal toxicity is expected und no classification is derived.

Inhalation: No acute inhalation study available is available. These studies were not proposed or conducted because exposure consideration point to a more likely dermal and oral exposure and according to the REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5 only information on two application routes needs to be provided, with test item administration via the most appropriate route.

Justification for selection of acute toxicity – dermal endpoint
Reliable and relevant study according to actual guidelines under GLP.

Justification for classification or non-classification

The available data for Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia indicate no acute toxic potential.

 

Acute oral toxicity study conducted with Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia (50%) reveals no deaths up to 2000 mg/kg bw. As additionally no concerns from a dermal toxicity study performed with 4000 mg/kg bw (AS 50%) or repeated dose studies can be derived a repetition of the oral study with higher dosage is not suggested and the the LD50 is expected to be clearly above 2000 mg/kg.

No information on inhalation toxicity is available which can lead to classification, therefore a classification for this endpoint is not possible.

In summary Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and Ammonia is, based on this results, not classified according to DPD (67/548/EEC) and the GHS (Regulation (EU) 1272/2008).

Labelling for acute toxicity:

GHS: no classification

DSD: no classification