Fatty acids, tall-oil, esters with trimethylolpropane

Endpoint summary

Description of key information

Skin irritation: not irritating, (OECD 404, analogue approach)
Eye irritation: not irritating, (OECD 405, analogue approach)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Study period:

23 Jan - 30 Jan 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions (no data on analytical purity; observation period only 7 days)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1992

Deviations:

yes

Remarks:

no data on analytical purity; observation period only 7 days

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

adopted in 1992

Deviations:

yes

Remarks:

no data on analytical purity; observation period only 7 days

GLP compliance:

yes

Remarks:

Department of health of the government of the United Kingdom, UK

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Chesire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually housed in suspended metal cages.
- Diet: certified Rabbit Diet (PMI Nutrition International, Nottingham, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17- 23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: the treated skin was covered with a 2.5 cm x 2.5 cm cotton gauze, held in place with strip of surgical adhesive tape. In addition to prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Very slight to well-defined erythema was noted in all animals (3/3) one hour after patch removal and at the 24 h observation. Very slight erythema noted in 2/3 animals skin at the 48 and 72 h observations.

Very slight to slight edema was noted in 2/3 animals on hour after patch removal and at 24 h observation. Very slight edema was observed in 1/3 animals at the 48 and 72 hour observation.

Other effects:

Light desquamation was noted at the two treated skin sites at the 7-day observation.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

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:

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

Adequacy of study:

key study

Study period:

31 Jan - 07 Feb 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions (no data on analytical purity; no eye washing performed after treatment)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted in 1987

Deviations:

yes

Remarks:

no data on analytical purity; no eye washing performed after treatment

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

adopted in 1992

Deviations:

yes

Remarks:

no data on analytical purity; no eye washing performed after treatment

GLP compliance:

yes

Remarks:

Department of health of the government of the United Kingdom, UK

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Chesire, UK
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually housed in suspended metal cages.
- Diet: certified Rabbit Diet (PMI Nutrition International, Nottingham, UK), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17- 23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

3 days
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

1 female and 2 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

No corneal or iris effects occurred during the study.

Moderate conjuctival irritation was observed in all treated eyes (3/3) one hour after treatment.
Minimal conjuctival irritation was noted in two treated eyes (2/3) at 24 h observation time.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for grouping of substances and read-across

There are no data available for the irritation/corrosion of Fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6). In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and VIII, 8.2 in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted. In accordance with Article 13 (1) of Regulation (EC) No 1907/2006 “information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set put in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).

Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity, the substance listed below are selected as reference substances for hazard assessment.

Overview irritation/corrosion

CAS	Skin irritation	Eye irritation
94581-09-6 Target substance	RA: CAS 403507-18-6	RA: CAS 403507-18-6
403507-18-6	Not irritating	Not irritating

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, tall-oil, triesters with trimethylolpropane (CAS 94581-09-6). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

 

Skin irritation

A primary dermal irritation study was performed with Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) comparable to OECD Guideline 404 and GLP (Sanders, 2002). The clipped skin of three male New Zealand White rabbits was exposed to 0.5 mL unchanged test material for 4 hours under semiocclusive conditions. The rabbits were observed for 3 days following exposure. Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the test substance. Very slight to well-defined erythema was noted in all animals one hour after patch removal and at the 24 h observation time point. Very slight erythema was seen for 2/3 animals at the 48 and 72 h observations. The mean erythema score over 24, 48 and 72 hours were 1.33 for animal #1 and #3 and 0.33 for animal #2. The mean edema scores were 0.33, 0, and 1.33 for animals #1, #2 and #3 respectively. All effects were at the latest reversible within 7 days. Thus, the test material is not considered irritating to the skin in this study.

 

Eye Irritation

Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was tested for its acute eye irritation potential in a study performed comparable to OECD Guideline 405 (Sanders, 2002). The undiluted test material (0.1 mL) was applied into the conjunctival sac of two male and one female New Zealand White rabbits. The animals were observed for 72 hours and reactions were assessed 1, 24, 48, and 72 hours after instillation according to the Draize scoring system. No corneal or iridal effects occurred during the study. Moderate conjuctival irritation was observed in all treated eyes one hour after application. Minimal conjuctival irritation was noted in two treated eyes (2/3 animals) at the 24 h observation time point. The mean conjunctivae scores over 24, 48 and 72 hours were 0.33 and 0 for animal #1 and #3 and 0 for animal #2. All effects were at latest reversibile within 48 hours. Thus, the test material is not considered irritating to the eyes in this study.

Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from structural analogue. The available study are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from structural analogue. The available study are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

The available data on skin/eye irritation potential of structural related substances do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.