Oligomerisation products of ethylene oxide with reaction products of rape oil and ethanolamine

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:

From 26 November 1998 to 21 December 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

A valid skin sensitisation test according to Magnusson & Kligman conducted comparable to guideline with acceptable restrictions is available, which is reliable with restrictions and adequate for classification and labelling purposes. Potency estimation is not mandatory when existing guideline and GLP conforming data are available, which were conducted before the new annex of the REACH Regulation entered into force. Moreover, no indication for skin sensitisation was observed in this study, thus, no dose response information is needed. For this reason and for reasons of animal welfare no additional LLNA was conducted.

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 32 days
- Weight at study initiation: 238-303 g
- Housing: kept in pairs in MAKROLON cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3ºC
- Humidity (%): 60±20%
- Photoperiod (hrs dark / hrs light): 12/12

Route:

intradermal

Vehicle:

other: sesame oil DAB

Concentration / amount:

intracutaneous injection: 0.001, 0.01, 0.1, 1, 2 and 5%
topical application: 0.2, 2, 10, 20, 50 and 100%

Route:

epicutaneous, occlusive

Vehicle:

other: sesame oil DAB

Concentration / amount:

intracutaneous injection: 0.001, 0.01, 0.1, 1, 2 and 5%
topical application: 0.2, 2, 10, 20, 50 and 100%

No. of animals per dose:

15 animals

Details on study design:

MAIN STUDY

Possible sensitising properties of the test compound were evaluated by administration of the test substance to the shoulder region, first by intracutaneous application (stage 1) and 7 days later by topical administration (stage 2, exposure time: 48 hours).
In a challenge test (stage 3) the test compound was again applied topically but to the flank region (exposure time: 24 hours). This area was then examined for reactions which might indicate sensitising properties to the test compound.

A. INDUCTION EXPOSURE
- Concentrations: Stage 1: Intracutaneous: 0.2%
Stage 2: topical: 10%
Stage 3: topical 0.01%

B. CHALLENGE EXPOSURE

- Day(s) of challenge: day 21
- Exposure period: 24 h
- Concentrations: 2 mL in left flank
2 ml in right flank

Erythema and eschar formation
no erythem: 0
slight erythema: 1
well-defined erythema: 2
moderate erythema: 3
severe erythema to slight eschar formation: 4
Maximum possible: 4

Oedema formation
no oedema: 0
slight oedema: 1
well-defined oedema: 2
moderate oedema: 3
severe oedema: 4
Maximum possible: 4

Positive control substance(s):

yes

Positive control results:

Animals of this strain treated with potassium dichromate exhibited a sensitising reaction.

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.01%

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Remarks:

The total number of animals in the negative group is not specified

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.01%

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

0 %

No. with + reactions:

0

Clinical observations:

none

Remarks on result:

no indication of skin sensitisation

Remarks:

The total number of animals in the negative control group is not specified

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

positive control

Dose level:

not applicable

Remarks on result:

positive indication of skin sensitisation

Remarks:

Number of animals in the positive control group as well as concentration of the reference susbtance not applicable

Concentration of Product (%)	Route of Administration	Animal no.	Hours after start of treatment
			24 h	48 h	72 h
5	intracutaneous	7	E3	E1	E1
2		7	E3	E1	E1
1		7	E1	E1	E1
0,1		8	E1	E1	0
0,01		8	0	0	0
0,001		8	0	0	0
non-depilated	topical
100		1	-	E2	E3#
50		1	-	E2	E2
20		2	-	E1	E1
10		2	-	E1	E1
2		3	-	E1	0
0,2		3	-	0	0
depilated	topical
100		4	E1	E2	E3-4##
50		4	E1	E2	E3-4##
20		5	0	E2	E3
10		5	0	E2	E2
2		6	0	E1	E1
0,2		6	0	E1	E1
0,1		9	0	E1	E1
0,01		9	0	0	0
0,001		10	0	0	0
0,0001		10	0	0	0

#: laceration, necrosis

##: eschar formation, laceration, necrosis

E1: slight erythema

E2: well-defined erythema

E3: moderate to severe erythema

0: no pathological findings

-: not examined, 48 -h exposure/no values available

Interpretation of results:

GHS criteria not met

Conclusions:

The product did not show any sensitising properties in guinea-pigs in a test model according to MAGNUSSON AND KLIGMAN.

Executive summary:

The purpose of this study was to determine the potencial of the product to provoke skin sensitisation reactions in guinea-pigs in a test model according to MAGNUSSON and KLIGMAN.

0.1 mL/animal (as a 0.2% concentration in sesame oil) chosen for the 1st (intracutaneous) induction stage and 2 ml/animal (as a 10% concentration in sesame oil) chosen for induction stage 2 (topical) produced a slight irritation in all animals. The challenge with 2 ml/animal (as a 0.01% concentration in sesame oil) revealed no sensitising properties.

The vehicle control animals treated with sesame oil in the same way during stages 1 and 2 and 2 ml of the product during the third stage also revealed no skin reactions.

Behaviour remained unchanged, body weight gain was within the normal range.

Under the present test conditions the product revealed no sensitising properties in guinea-pigs in a test according to MAGNUSSON and KLIGMAN.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Under the test conditions the test substance revealed no sensitising properties in guinea-pigs.

The test material is not considered to be a skin sensitiser in a skin sensitisation test in guinea-pigs according to Magnusson and Kligman (maximisation test) using OECD 406 and therefore no classification is necessary.

Migrated from Short description of key information:
Study was performed under corresponding guideline OECD 406 and under GLP.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Migrated from Short description of key information:
Inhalation was not considered as a likely route of entry.

Justification for classification or non-classification

- skin sensitisation:

Based on the above stated assessment of the skin sensitisation potential, the test item does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.