Fatty acids, tall-oil, compds. with triethanolamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6th March 2017- 19th April 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

OECD 406

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes

Type of study:

Buehler test

Justification for non-LLNA method:

A Buehler test was used for R&D purposes and worldwide acceptance, so an LLNA should not ethically be completed based on animal welfare reasons.

Species:

guinea pig

Strain:

Hartley

Sex:

female

Details on test animals and environmental conditions:

Prior to use, all animals were acclimated for at least five days. Animals were individually housed in wire mesh suspension cages. The animals were maintained on a 12-hour cycle light controlled room, at a temperature of 64° - 79°F and a relative humidity of 30-70%. The animals were maintained according to the recommendations contained in the National Academy Press 2011: “Guide for the Care and Use of Laboratory Animals.” The animals were supplied Purina Guinea Pig Chow and tap water ad libitum during both acclimation and test periods. Tox Monitor Laboratories has daily access to feed analysis; water analysis from the city of Chicago is on file. There were no contaminants in either the feed or the water that would be expected to affect the outcome of this study.

Route:

epicutaneous, semiocclusive

Vehicle:

water

Remarks:

Deionized

Concentration / amount:

0.4ml of 20 % concentration

Day(s)/duration:

6 hours

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

No.:

#1

Route:

epicutaneous, semiocclusive

Vehicle:

water

Concentration / amount:

0.4ml of 5% concentration

Day(s)/duration:

6 hours

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

20 animals dosed for both Induction and Challenge test.

Details on study design:

The test substance was evaluated for sensitization potential by applying 0.4 ml at a 20% concentration directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of TOFA TEA salt, LAB 4440 at 5% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.

Challenge controls:

Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 5% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.

Positive control substance(s):

yes

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5% concentration

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5% concentration

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

5% concentration

No. with + reactions:

0

Total no. in group:

6

Remarks on result:

no indication of skin sensitisation

Group:

positive control

Remarks on result:

not measured/tested

Interpretation of results:

GHS criteria not met

Remarks:

NO Classified for Skin Sensitization

Conclusions:

Following primary challenge of ,Test Substance, at 5% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced. Therefore in accordance with the criteria set in the CLP guidiance document the test substance will not be classified for skin sensitization.

Executive summary:

The test substance identified as TOFA TEA salt, LAB 4440 was tested for dermal sensitization potential utilizing a Buehler Technique Guinea Pig Sensitization Protocol. The test substance was evaluated for sensitization potential by applying 0.4 ml at a 20% concentration directly into Hilltop Chambers® and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals. Two weeks after the final application the animals received a topical primary challenge dose (6 hour contact) of TOFA TEA salt, LAB 4440 at 5% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application. Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 5% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary. Following primary challenge of TOFA TEA salt, LAB 4440 at 5% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced. Therefore in accordance with the criteria set in the CLP guidiance document the test substance will not be classified for skin sensitization.

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Justification for classification or non-classification

The study has been conducted in accordance with the OECD 406 and has been considered when determining the skin sensitization endpoint of the test material. This key study was used for classifiaction purposes in accordance with the criteria set in the CLP guidiance document. The Test substance was identified to be slighly irritating at 20% and non irritating at 5%. The 20% dose of the test substance was used for the induction and 5% dose was used for the challenge phase of the study. Following primary challenge of the test substance at 100% concentration, the incidence of grade 1 response or greater in the test group (0 of 20) was compared to that of the naive control group (0 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.

Therefore the test substacne does not meet the criteria for skin sensitization in accordance with the creteria set forth in the CLP guidiance document.