oils, palm, propoxylated

Endpoint summary

Description of key information

The results of a reliable in vitro skin corrosion and a reliable in vitro skin irritation study employing human skin tissue (eipdermis keratinocytes) exposed to the undiluted substance indicates that the substance is non-corrosive and non-irritant to human skin.

A structurally similar substance produced a primary irritation index of 0.0 in a reliable in vivo study performed to assess the irritancy potential of the substance to the skin of New Zealand White rabbit. The substance is classified as a non-irritant according to Draize classification scheme.

A structurally similar substance produced a maximum group mean score of 10.0 in a reliable in vivo study performed to assess the irritancy potential of the substance to the eye of New Zealand White rabbit. The substance is classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 January 2016 to 22 January 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Version / remarks:

28 July 2015

Deviations:

yes

Remarks:

An additional procedure using freeze-killed tissues was performed, but the results of this was not used because there was negligible interference. This deviation was considered not to affect the purpose or integrity of the study.

GLP compliance:

yes

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Source strain:

not specified

Justification for test system used:

As specified in the OECD Guidelines for this type of testing.

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Duration of treatment / exposure:

3-minutes
60-minutes

Number of replicates:

Duplicate tissues were exposed to the substance for each time point. The MTT assays were conducted in triplicates.

Vehicle:

unchanged (no vehicle)

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

3-minute exposure

Value:

88.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

60-minute exposure

Value:

103.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was considered to be non-corrosive to the skin.

Executive summary:

In an in vitro skin corrosion study human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 3-minutes and 1-hour. There was 88.8% and 103.7% tissue viability following the 3-minutes and 1-hour exposure points, respectively. Resultantly, the substance is considered to be non-corrosive to skin.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 February 2016 to 22 February 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Version / remarks:

28 July 2015

Deviations:

no

GLP compliance:

yes

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Duration of treatment / exposure:

15-Minute exposure period

Duration of post-treatment incubation (if applicable):

42-Hour post-exposure incubation period.

Number of replicates:

Triplicate

Irritation / corrosion parameter:

% tissue viability

Value:

84.2

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

The substance was classified as a non-irritant.

Executive summary:

In an in vitro skin irritation study human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 15-minutes. There was 84.2% tissue viability following the 15-minute exposure point. Resultantly, the substance is considered to be a non-irritant to human skin.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across to K1 study therefore K2 is the maximum Klimisch value.

Justification for type of information:

Read-across approach - see read-across justification in section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of undiluted test material was applied.

Duration of treatment / exposure:

1 hour and 3 minute exposure periods

Observation period:

1, 24, 48 and 72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsal / flank area
- % coverage: 2.5 X 2.5 cm
- Type of wrap if used: Cotton gauze patch secured with a surgical adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water.


SCORING SYSTEM: Draize Classiification Scheme

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 1, 24, 48 and 72 hour

Score:

0

Max. score:

4

Remarks on result:

other: Max. score is 4 for erythema and 4 for edema.

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The substance produced a primary irritation index of 0.0 and was classified as a non-irritant according to Draize classification scheme.

Executive summary:

An in vivo study was performed to assess the irritancy potential of the substance to the skin of New Zealand White rabbit according to OECD TG 404 (Acute Dermal Irritation/Corrosion). A single 4 -hour, semi-occluded application of the substance to the intact skin of 3 rabbits produced no evidence of skin irritation. Three-minute and 1 -hour semi-occluded applications of the substance to the intact skin of 1 rabbit produced no evidence of skin irritation. The substance produced a primary irritation index of 0.0 and therefore classified as non-irritant to rabbit skin according to the Draize classification scheme.

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:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across to K1 study therefore K2 is the maximum Klimisch value.

Justification for type of information:

Read-across approach - see read-across justification in section 13.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye was used as control

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Observation period (in vivo):

1, 24, 48 and 72 hour

Number of animals or in vitro replicates:

3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24 hrs

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24h-observation. Treated eyes appeared normal at the 48-hour and 72-hour observation.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance did not meet the criteria for classification according to EU labelling.

Executive summary:

The irritatncy potential of the substance to the eye of New Zealand White rabbit was assessed according to the OECD TG 405 (Acute Eye Irritation/Corrosion). In the absence of skin irritation data a Rabbit Enucleated Eye Test was performed prior to the in vivo study and the results from this study indicated that the substance qwas unlikely to cause severe ocular irritancy. A single application of the substance to the unwashed eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. the substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on the findings of reliable studies conducted on the substance and a structural analogue, classification of the substance is not justified.