Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol

Endpoint summary

Description of key information

The assessment is based on a weight of evidence using test material, CAS RN 63310-16-7, which was determined to have a NOAEL of 1000 mg/kg/day in a 28 day repeat dose study performed in accordance with OECD 410.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The study was conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. It was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997).

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No repeated dose studies are available for the registered substance. However, repeat dose data is available for the raw materials, which are also the potential breakdown products.

The dermal repeat dose toxicity of CAS RN 63310-16-7 was determined following a methodology equivalent to standardised guideline OECD 410. Groups of fifteen male and fifteen female rats were dermally administered 20% w/w, 50% w/w or 100% test material in mineral oil for a period of 4 weeks. Animals were treated for 6 hours per day, six times a week during week 1, five time per week during weeks 2 and 3 and four times a week during week 4. An additional group of fifteen males and fifteen females were treated with mineral oil alone and served as controls. Clinical observations, bodyweights and skin irritation parameters were measured throughout the study. At the end of the scheduled period, the animals were killed and subjected to an examination post mortem. Cardiac blood samples were taken for clinical pathology, selected organs were weighed and specified tissues were taken for subsequent histopathology examination. Under the conditions of the study, subacute dermal treatment of male and female rats with test material did not cause any mortality or any signs of toxicity. Mild skin irritation appeared in both sexes during the first week of the study, but subsided thereafter. The statistically significant changes in mean serum calcium levels, serum phosphorus levels, blood urea nitrogen , blood urea nitrogen/creatinine ratios, left ovary weight, left ovary/body weight ratio and brain weight were not considered biologically significant. No other significant changes occurred that could be attributed to treatment with the test material. The No Observed Adverse Effect Level was subsequently determined to be 1000 mg/kg bw/day.

Dermal repeated dose studies (14 week and 104 week) were conducted on rats and mice using CASRN 68603-42-9 (NTP, 2001). Results in the table below highlight that the NOAEL for systemic toxicity was not established based on changes in organ weights at 25 mg/kg/day and above. Additionally, local irritation was reported at 25 mg/kg/day for all studies and the NOAEL was not established.

CAS Number	Repeat Dose Studies	Reference
68603-42-9	14-week Rat (F344/N):0, 25, 50, 100, 200 or 400 mg/kg/day LOAEL (local irritation) = 25 mg/kg/day NOAEL (local irritation) = Not established NOAEL (systemic toxicity, males) = 400 mg/kg/day(highest dose tested) LOAEL (systemic toxicity, females) = 25 mg/kg/day(based on absolute kidney weight changes) NOAEL (systemic toxicity, females) = Not established Similar to OECD 411   104-week Rat (F344/N):0, 50 or 100 mg/kg/day LOAEL (local irritation) = 50 mg/kg/day NOAEL (local irritation) = Not established NOAEL (systemic toxicity, males) = 100 mg/kg/day(highest dose tested) LOAEL (systemic toxicity, females) = 50 mg/kg/day(based on increased incidence of renal tubule hyperplasia) NOAEL (systemic toxicity, females) = Not established	NTP, 2001; EPA FND, 2010
	14-week Mouse (B6C3F1):0, 50, 100, 200, 400 or 800 mg/kg/day LOAEL (local irritation) = 50 mg/kg/day NOAEL (local irritation) = Not established LOAEL (systemic toxicity) = 400 mg/kg/day(based on increased liver and kidney weight) NOAEL (systemic toxicity) = 200 mg/kg/day Similar to OECD 411   104-105 weekMouse (B6C3F1):0, 100 or 200 mg/kg/day LOAEL (local irritation) = 100 mg/kg/day NOAEL (local irritation) = Not established NOAEL (systemic toxicity) = Not established (organ weights, basis for NOAEL in 14-week study, were not measured)	NTP, 2001; EPA FND, 2010
63310-16-7	No target organ effects,                                                                      3 NOEL = ca. 1.0 ml/kg (highest dose tested) Similar to OECD 407	Dukeet al.,1982

The dermal repeat dose study with CAS RN 63310-16-7 is used as the authoritative study for classification and risk assessment purposes. Dermal exposure is the only anticipated potential route of exposure; therefore, the borated glycerol ester, which is represented by CAS RN 63310-16-7 is the most relevant toxicology functionality and closest analog.

REFERENCES

 

Duke, C.E., Cisson, C.M., and Wong, Z.A. 1982. Twenty-eight Day Repeated Dermal Study of[redacted]in Adult Male and Female Rats. Internal Chevron Environmental Health Center. Report No. SOCAL 1873.

 

Fatty Nitrogen Derived (FND) Amide Category EPA Hazard Characterization. 2010.

 

National Toxicology Program (NTP). 2001. “Diethanolamine Condensate (CAS No. 68603-42-9) in F344/N Rats and B6C3F1 Mice (Dermal Studies)”. NTP TR 479/NIH. Publication No. 01-3969.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:
Currently, there is no existing repeat dose toxicology data on the registered substance (CASRN 1428353-74-5); however, acute dermal toxicity data exist for borated glycerol monooleate (CASRN 63310-16-7) and one of the breakdown products of the registered substance amines, coco, N, N-bis (hydroxyethyl) (CASRN 68603-42-9). The read across repeated dose toxicity data demonstrates that the substance to be registered is not expected to be toxic following repeated dermal exposure.

Justification for classification or non-classification

In accordance with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for specific organ toxicity, repeated dose. The effects observed in the available study are not considered to be toxicologically significant and do not indicate any signs of organ dysfunction.