Fatty acids, tall-oil, reaction products with acrylic acid

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:

december 1973

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

other: Buehler, EV. Delayed contact hypersensitivity in the guinea pig. Arch Dermat 91, February 1965.

Deviations:

not specified

Principles of method if other than guideline:

no data

GLP compliance:

no

Remarks:

(study performed prior to GLP)

Type of study:

Buehler test

Justification for non-LLNA method:

The study was perfomed before the LLNA method was approved and it is considered relevant and conclusive.

Species:

guinea pig

Strain:

other: albino

Sex:

not specified

Details on test animals and environmental conditions:

No data

Route:

epicutaneous, occlusive

Vehicle:

propylene glycol

Concentration / amount:

Range-finding: 0.1, 1.0 and 10.0% (w/v) solution of Diacid 1550 in Propylene Glycol and undiluted
Main study: 0.1% (w/v) solution of Diacid 1550 in Propylene Glycol

Route:

epicutaneous, occlusive

Vehicle:

propylene glycol

Concentration / amount:

Range-finding: 0.1, 1.0 and 10.0% (w/v) solution of Diacid 1550 in Propylene Glycol and undiluted
Main study: 0.1% (w/v) solution of Diacid 1550 in Propylene Glycol

No. of animals per dose:

Range-finding: 2 animals per dose
10 animals in the test group and 4 animals in the control group

Details on study design:

RANGE FINDING TESTS:
0.1%, 1.0%, 10.0% and undiluted Diacid were tested to establish the irritation threshold of the material. The maximum non-irritating concentration of the test material was used during induction and challenge exposure.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Test groups: 10 guinea pigs
- Control group: 4 guinea pigs
- Site: near the midline of the shaved back of the guinea pig
- Frequency of applications: 9
- Duration: 6 hours
- Concentrations: 0.1 % (w/v) solution of Diacid in proylene glycol

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: no data
- Exposure period: five weeks after the initial exposure
- Test groups: 10 guinea pigs
- Control group: 4 guinea pigs
- Site: No information available, duplicate patches applied
- Concentrations: 0.1% (w/v) solution of Diacid 1550 in propylene glycol
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:

Four control animals were not treated during the induction phase and treated during challenge phase (negative controls).

Positive control substance(s):

no

Positive control results:

no data

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0.1%

No. with + reactions:

0

Total no. in group:

4

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: none.

Group:

positive control

Remarks on result:

not measured/tested

Remarks:

twice a year positive controls were tested in the facility, but results were not reported in the study report.

The application sites were graded 24 and 48 hours after the initial insult, 24 and 48 hours after each intermediate insult, and 24 and 48 hours after challenge. None of the animals showed any signs of erythema or edema.

Results of the range-finding test are presented in the table below.

Test material concentration	Animal number	Scores following application
		Site 1				Site 2
		24 hr		48 hr		24 hr		48 hr
		Er.	Ed.	Er.	Ed.	Er.	Ed.	Er.	Ed.
0.1%	1	0	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0	0
1.0%	3	1	0	1	0	1	0	1	0
	4	1	0	1	0	1	0	1	0
10.0%	5	2	0	2	0	2	0	2	0
	6	2	0	2	0	2	0	2	0
Undiluted	7	3	2	3	2	3	2	3	1
	8	3	2	3	2	3	2	3	2

Interpretation of results:

GHS criteria not met

Conclusions:

In a skin sensitisation test according to Buehler, 0.1% Diacid 1550 in propylene glycol did not induce skin sensitisation in albino guinea pigs under the conditions of this test.

Executive summary:

A skin sensitisation study was performed in accordance with the Buehler method to determine the skin sensitising potential of Diacid 1550. Ten albino guinea pigs were used. During induction, each animal was insulted with a single closed patch containing 0.1% Diacid, for a total of nine times. Five weeks after the initial exposure, the 10 test animals and 4 previously untreated controls were challenged with duplicate patches. The application sites were graded for skin reactions 24 and 48 hours after the initial insult, after each intermediate insult and after challenge. None of the exposed animals showed any skin reactions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

A skin sensitisation study was performed in accordance with the Buehler method to determine the skin sensitising potential of Diacid 1550. Ten albino guinea pigs were used. During induction, each animal was insulted with a single closed patch containing 0.1% Diacid, for a total of nine times. Five weeks after the initial exposure, the 10 test animals and 4 previously untreated controls were challenged with duplicate patches. The application sites were graded for skin reactions 24 and 48 hours after the initial insult, after each intermediate insult and after challenge. None of the exposed animals showed any skin reactions

Migrated from Short description of key information:
Buehler test (0.1% Diacid): not sensitising (guinea pig)

Justification for selection of skin sensitisation endpoint:
One study available which was performed according to the Buehler method with a low concentration of 0.1%; this concentration represented the maximum non-irritating concentration.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

.No study is available for respiratory sensitisation.

Justification for classification or non-classification

Based on the available information, Diacid 1550 does not need to classified as sensitising to the skin in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2002/EC.