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

Endpoint summary

Description of key information

GLP guideline studies are availalbe for both skin and eye irritation for the notified substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June 12, 2015 to September 23, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Number of animals:

3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.89

Reversibility:

other:

Remarks:

Slight erythema was present in one animal throughout the study period. Erythema reversed in remaining two animals by day 14

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.11

Reversibility:

other:

Remarks:

Not present in 2 animals. Did not reverse in one animal through study period of 21 days.

Interpretation of results:

GHS criteria not met

Conclusions:

Primary Irritation Index (PII) for SP5076 was 1.8. The Draize scores at 24, 48, and72 hours after patch removal for erythema and edema for individual animals were:Erythema:Animal 1 (24, 48, 72 hr): 1, 2, 2Animal 2 (24, 48, 72 hr): 2, 2, 2Animal 3 (24, 48, 72 hr): 2, 2, 2EdemaAnimal 1 (24, 48, 72 hr): 0, 0, 0Animal 2 (24, 48, 72 hr): 0, 0, 1Animal 3 (24, 48, 72 hr): 0, 0, 0

Executive summary:

The substance resulted in a 24 -72 hr mean erythema and edeam score of 1.89 and 0.06, respecitively and does not meet the CLP criteria for classification as a skin irritant. This was a GLP OECD 404 guideline study. There were no deaths or remarkable body weight changes noted during the study. All 3 rabbits had very slight erythema to slight erythema, and only 1 of these rabbits had very slight to slight edema. While erythema had resolved by study day 14 for 2 of the rabbits, very slight erythema and slight edema were still present at the last observation period (study day 21) for the remaining rabbit. The only other dermal finding was desquamation on study day 14 for 2 rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 17, 2016 to May 4, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

study period (unwashed)

Observation period (in vivo):

17 days

Duration of post- treatment incubation (in vitro):

unwashed

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 14 days

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Reversibility:

fully reversible within: 4 days

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Reversibility:

fully reversible within: 17 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Reversibility:

fully reversible within: 7 days

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

The 24-, 48-, and 72-hour post-instillation Draize scores for SP5076 were 18.7/110, 17.0/110, and 17.7/110, respectively. All positive ocular irritation subsided by study day 14.

Executive summary:

In a GLP guideline study, the substance caused irritation that meets the CLP criteria for classification as category 2A. There were no deaths or remarkable body weight changes noted during the study. The only clinical observations noted during the study were ocular-related and consisted mainly of partial and/or complete closure of the right eye. Positive corneal irritation, conjunctival irritation, and iridal irritation were noted for all rabbits. Iridal and corneal irritation subsided by study day 4 and 14, respectively. Positive conjunctival irritation subsided by study day 7; however, conjunctival redness did not subside until study day 17. Clear discharge was noted in all 3 rabbits and subsided by 72 hours post-instillation. Two of 3 rabbits had some fluorescein staining noted at 24 hours post-instillation which subsided by study day 4.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN

The substance resulted in a 24 -72 hr mean erythema and edeam score of 1.89 and 0.06, respecitively and does not meet the CLP criteria for classification as a skin irritant. This was a GLP OECD 404 guideline study. There were no deaths or remarkable body weight changes noted during the study. All 3 rabbits had very slight erythema to slight erythema, and only 1 of these rabbits had very slight to slight edema. While erythema had resolved by study day 14 for 2 of the rabbits, very slight erythema and slight edema were still present at the last observation period (study day 21) for the remaining rabbit. The only other dermal finding was desquamation on study day 14 for 2 rabbits.

 

EYE

In a GLP guideline study, the substance caused irritation that meets the CLP criteria for classification as category 2A. There were no deaths or remarkable body weight changes noted during the study. The only clinical observations noted during the study were ocular-related and consisted mainly of partial and/or complete closure of the right eye. Positive corneal irritation, conjunctival irritation, and iridal irritation were noted for all rabbits. Iridal and corneal irritation subsided by study day 4 and 14, respectively. Positive conjunctival irritation subsided by study day 7; however, conjunctival redness did not subside until study day 17. Clear discharge was noted in all 3 rabbits and subsided by 72 hours post-instillation. Two of 3 rabbits had some fluorescein staining noted at 24 hours post-instillation which subsided by study day 4.

Justification for classification or non-classification

Skin

In accordance with with criteria for classification as defined in Annex I, Regulation 1272/2008, the test material is not classified for skin irritation.

Eye

In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material is classified as an eye irritant, category 2A.