N,N-bis(2-hydroxypropyl)benzamide

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 Apr 11th to May 22nd, 2001

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:

Study was perfomed in 2001. At the time there was no OECD guideline regarding LLNA method.

Species:

guinea pig

Strain:

other: Ibm: GOHI (Himalayan spotted)

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd Biotechnology and Animal Breeding Division, Wolferstrasse 4, CH-4414 Fullinsdorf/Switzerland
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 367-388 g
- Housing: Individually in makrolon type-4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3418, batch no. 33/00 and 90/01, guinea pig maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12

Route:

intradermal and epicutaneous

Vehicle:

corn oil

Remarks:

selected on the basis of preliminary solubility testing

Concentration / amount:

Intradermal induction: 3% in corn oil
Epidermal induction: 50% in corn oil
Epidermal challenge: 15% in corn oil

Route:

epicutaneous, occlusive

Vehicle:

corn oil

Remarks:

selected on the basis of preliminary solubility testing

Concentration / amount:

Intradermal induction: 3% in corn oil
Epidermal induction: 50% in corn oil
Epidermal challenge: 15% in corn oil

No. of animals per dose:

10

Positive control substance(s):

yes

Remarks:

2-mercaptobenzothiazole

Positive control results:

All test animals (10) showed discrete/patchy to moderate/confluent erythema after the challenge treatment with 2-mercaptobenzothiazole at 1% (w/w) in mineral oil.

Hours after challenge:

24

Group:

test chemical

Dose level:

15% in corn oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Remarks on result:

other: . Hours after challenge: 24.0. Group: test group. Dose level: 15% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Hours after challenge:

48

Group:

test chemical

Dose level:

15% in corn oil

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Remarks on result:

other: . Hours after challenge: 48.0. Group: test group. Dose level: 15% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Hours after challenge:

24

Group:

negative control

Dose level:

0%

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

None

Remarks on result:

other: . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Interpretation of results:

GHS criteria not met

Conclusions:

No toxic symptoms were evident in the guinea pigs of the test group.
Hence, the substance is not sensitizer.

Executive summary:

A Maximisation test was performed in accordance with OECD Guideline 406.

The intradermal induction of sensitization in the test group was perfomed in the nuchal region with a 3% dilution of the test item in corn oil and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50% in corn oil one week after the intradermal induction. The animals in the control group were intradermally induced with corn oil and FCA/physiological saline and epidermally induced with corn oil under occlusion.

Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 15% in corn oil and corn oil alone under occlusive dressing.

Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.

No toxic symptoms were evident in the guinea pigs of the control or the test group. No deaths occured. None of the control and test animals showed skin reactions after the challenge treatment with the substance at 15% in corn oil.

2 -mercaptobenzothiazole was used as positive control. All test animals (10) showed discrete/patchy to moderate/confluent erythema after the challenge treatment with 2-mercaptobenzothiazole at 1% (w/w) in mineral oil.

Based on these findings, the experiment was considered valid and the conclusion is that the substance is not sensitizer.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

No toxic/sensitising effects were evident in a valid Maximisation test study on Guinea pigs, according to OECD TG 406.

All animals survived the test and the substance showed no treatment related effects.

On the basis of this result, the substance should not be classified as sensitizer, according to REGULATION (EC) No 1272/2008.