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

Endpoint summary

Description of key information

ORAL: LD50 =  > 2000 mg/kg male/female rat, OECD 423, Weinberg JT (2015)
DERMAL: LD50 =  > 2000 mg/kg male/female rat, OECD 402, Weinberg JT (2015)

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:

March 9, 2015 to June 11, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

2000 mg/kg

No. of animals per sex per dose:

6

Control animals:

no

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Based on:

test mat.

All six animals in the 2000 mg/kg group survived to the scheduled necropsy (study

day 14).

Clinical observations were noted on study day 0 for 4 females at 2000 mg/kg and

consisted of soft feces, diarrhea, wet or dried yellow material on various body surfaces

and/or wet brown material on the anogenital area. In addition, dried yellow material on

the ventral trunk was observed for one of these females on study day 1.

Body weights were unaffected. There were no test substance-related macroscopic

findings.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the estimated LD50 was greater than 2000 mg/kg when administered as a single oral dose in female albino rats.

Executive summary:

The acute oral toxicity was evaluated via oral gavage at a limit dose of 2000 mg/kg in female rats. All animals survived to scheduled necropsy. The LD50 is > 2000 mg/kg

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Guideline GLP study on notified substance.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

March 9, 2015 to June 11, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not required

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

There were no deaths, clinical observations, or remarkable body weight changes. There

were no gross necropsy findings for any examined tissues.

All animals were noted with very slight (grade 1) to slight (grade 2) erythema.

Desquamation, encrustation, scabbing within dose site, and pinpoint scabbing were

observed for 7, 3, 3, and 2 animals, respectively. Exfoliation was limited to 1 animal.

Very slight erythema, desquamation, and pinpoint scabbing were present for the same

animal at study termination.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the estimated LD50 was greater than 2000 mg/kg when administered once dermally for 24 hours to the clipped, unabraded skin of male and female albino rats.

Executive summary:

The dermal LD50 was > 2000 mg/kg in a guideline GLP study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Guideline GLP study on notified substance.

Additional information

ORAL

The acute oral toxicity was evaluated via oral gavage at a limit dose of 2000 mg/kg in female rats. All animals survived to scheduled necropsy. There were no observations of test substance related macroscopic findings. The LD50 is > 2000 mg/kg.

 

DERMAL

The acute dermal toxicity was evaluated at a limit dose of 2000 mg/kg in male and female rats. All animals survived to scheduled necropsy. There were no observations of test substance related macroscopic findings and no gross necropsy findings for any examined tissues. The LD50 is > 2000 mg/kg.

 

INHALATION

The generation of inhalable forms of the test material is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.

Justification for classification or non-classification

ORAL

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute oral toxicity as no signs of toxicity were noted in the available studies.

DERMAL

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute dermal toxicity as no signs of toxicity were noted in the available studies.