Tall oil, reaction products with ethanolamine

Endpoint summary

Description of key information

The skin irritation potential of the teat item was assessed in accordance with OECD Guideline 404.  The test item produced a primary irritation index of 1.83 (1.33 for erythema formation and 0.5 for edema formation) and was classified to be mild-irritant to rabbit skin according to the Draize classification scheme but not classified according to EU regulation. No corrosive effects were noted.  The eye irritancy potential of the test item was assessed in accordance with OECD Guideline 405.  The test item produced a maximum group mean score of 0.0 for cornea opacity, of  0.0 for iris damage, of 1.00 for conjunctival redness and 0.66 for conjunctival chemosis.  As such, the test item did not met the criteria for classification.  

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:

02 December to 09 December 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

At the start of the study the animals weighed 2.61 or 2.90 kg and were twelve to twenty weeks old.
Acclimatation period of at least 5 days.
The animals individually housed.
Free access to water and food.
Temperature between 17 and 23°C
Humidity between 30 and 70%
The relative air exchange was at least fifteen changes per hour and the lighting was controlled to give 12 hours continuous light (06.00 to 18.00) and twelve hours darkness.

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 mL of the test item

Duration of treatment / exposure:

Four hours after application the corset and patches were removed from each animal and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.

Observation period:

Immediately following removal of patches and approximatively 1, 24, 48 and 72 hours later examination for evidence of primary irritation and scored according to the Draize scoring.

Number of animals:

2 males

Details on study design:

On the back of the rabbit. Product directly applied to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches the trunk of each rabbit was strapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 74879 (male)

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 74880 (male)

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74879 (male)

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 74880 (male)

Irritant / corrosive response data:

Very slight erythema was noted at one treated skin site immediately after patch removal.
Well-defined erythema and very slight edema were noted at one treated skin site with very slight and very slight edema noted at the other treated skin site 1 hour after patch removal.
Well-defined erythema and very slight edema were noted at both treated skin sites at the 24-Hour observation with very slight erythema, with or without very slight edema, noted at both treated skin site at the 48-Hour observation. Very slight erythema persisted at both treated skin sites at the 72-Hour observation.
Both treated skin sites appeared normal at the 7-Day observation.

Other effects:

The body weight of the animal #74879 increased from 2.61 to 2.80 kg at day 3.
The body weight of the animal #74880 increased from 2.90 to 3.11 kg at day 3.

Interpretation of results:

GHS criteria not met

Conclusions:

The skin irritation potential of the teat item was assessed in accordance with OECD Guideline 404. The test item produced a primary irritation index of 1.83 (1.33 for erythema formation and 0.5 for edema formation) and was classified to be mild-irritant to rabbit skin according to the Draize classification scheme but not classified according to EU regulation. No corrosive effects were noted.

Executive summary:

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and very slight edema. Both treated skin sites appeared normal at the 7-Day observation.

Conclusion

The test item produced a primary irritation index of 1.83 (1.33 for erythema formation and 0.5 for edema formation) and was classified to be mild-irritant to rabbit skin according to the Draize classification scheme but not classified according to EU classification. No corrosive effects were noted.

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:

15 December 2014 to 08 January 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Due to technician error the initial pain reaction was not recorded for the first treated animal. This deviation was considered not to affect the purpose or integrity of the study.

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Due to technician error the initial pain reaction was not recorded for the first treated animal. This deviation was considered not to affect the purpose or integrity of the study.

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Start of the study the animals weighed 2.30 or 2.85 kg and were twelve to twenty weeks old.
Acclimatization period of at least five days.
Individually housed in suspended cages.
Free access to mains drinking water and food.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively.
THe rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye serves as control

Amount / concentration applied:

0.1 mL of test item

Duration of treatment / exposure:

No rinse.

Observation period (in vivo):

Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment.
An additional observation was made on Day 7 to assess the reversibility of the ocular effects.

Number of animals or in vitro replicates:

2

Details on study design:

Only animals free of ocular damage were used.
The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made.

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 74897 (male)

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: 74897 (male)

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74897 (male)

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74897 (male)

Irritation parameter:

cornea opacity score

Remarks:

opacity

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: 74903 (male)

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: 74903 (male)

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74903 (male)

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean score

Time point:

other: 24, 48 and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: 74903 (male)

Irritant / corrosive response data:

No corneal effects were noted during the study.
Iridial inflammation was noted in one treated eye 1 hour after treatment.
Moderate conjunctival irritation was noted in both treated eyes 1 hour after treatment. Moderate conjunctival irritation was noted in one treated eye with minimal conjunctival irritation noted in the other treated eye at the 24-Hour observation. Minimal conjunctival irritation was noted in both treated eyes at the 48-Hour observation.
Both treated eyes appeared normal at the 72-Hour observation.

Other effects:

One animal showed no gain in body weight and the other animal showed expected gain in body weight during the study.

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The eye irritancy potential of the test item was assessed in accordance with OECD Guideline 405. The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.00 for conjunctival redness and 0.66 for conjunctival chemosis. As such, the test item did not met the GHS criteria for classification.

Executive summary:

Introduction

The study was performed in accordance with OECD OECD Guideline No. 405 and EU Method B.5 to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

Results

A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both treated eyes appeared normal at the 72-Hour observation.

Conclusion

The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.00 for conjunctival redness and 0.66 for conjunctival chemosis; the conclusion is that the substance is not irritating.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation

Introduction

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit.

Results

A single 4-Hour, semi-occluded application of the test item to the intact skin of two rabbits produced well-defined erythema and very slight edema. Both treated skin sites appeared normal at the 7-Day observation.

Conclusion

The test item produced a primary irritation index of 1.83 (1.33 for erythema formation and 0.5 for edema formation) and was classified to be mild-irritant to rabbit skin according to the Draize classification scheme but not classified according to EU classification. No corrosive effects were noted.

Eye Irritation

Introduction

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit.

Results

A single application of the test item to the non-irrigated eye of two rabbits produced iridial inflammation and moderate conjunctival irritation. Both treated eyes appeared normal at the 72-Hour observation.

Conclusion

The test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.00 for cunjuctivae redness and 0.66 for cunjunctivae chemosis; the conclusion is that the substance is not irritating.

Justification for classification or non-classification

In the skin irritation study, the test item produced a primary irritation index of 1.83 for skin irritancy and no corrosive effects were noted. Furthermore, in the eye irritation study, the test item produced a maximum group mean score of 0.0 for cornea opacity, of 0.0 for iris damage, of 1.00 for conjunctivae redness and 0.66 for conjunctivae chemosis. As such, the test item deos not meet the criteria for classification and can be considered to be non-irritating to skin and eyes.