1,3-Dimethoxyphthalan

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:

supporting study

Study period:

2000-02-02 to 2000-03-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Investigations performed were in conformance with the Directive 96/54/EC, B.6 and with the OECD Guideline 406. The guinea pig maximisation test was used as a well known and sensitive method.

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor/CHFERT
- Expiration date of the lot/batch: June 2000

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the reefrigerator, in the dark
- Solubility and stability of the test substance in the solvent/vehicle: Unsoluble

Species:

guinea pig

Strain:

other: HsdPoc:DH

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: Yes
- Microbiological status of animals, when known:
- Age at study initiation: 6 Weeks old
- Weight at study initiation: 347-432 g
- Housing: Makrolon cages type III
- Diet (e.g. ad libitum): Altromin Standard Diet No. 3022
- Water (e.g. ad libitum): Tap water
- Acclimation period: 2 weeks
- Indication of any skin lesions:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 48
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12
- IN-LIFE DATES: From: To:

Route:

intradermal

Vehicle:

corn oil

Concentration / amount:

5%/ 0.1mL

Route:

epicutaneous, occlusive

Vehicle:

acetone/olive oil (4:l v/v)

Concentration / amount:

100%

Day(s)/duration:

48 hours

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

acetone/olive oil (4:l v/v)

Concentration / amount:

50%

Day(s)/duration:

1

No. of animals per dose:

20 females

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48
- Site: cranial, middle, caudal

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Site: Left flank for substance and right flank for vehicle
- Concentrations: 0.5 mL of test substance
- Evaluation (hr after challenge): 24 and 48 hr after exposure

Positive control substance(s):

yes

Positive control results:

The last check was performed with Hexyl cinnamic aldehyde. 10 females were tested for the positive control substance group. 8/10 animals had a positive skin reaction.

Reading:

rechallenge

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

0

Total no. in group:

20

Remarks on result:

no indication of skin sensitisation

Reading:

rechallenge

Hours after challenge:

24

Group:

negative control

Dose level:

0

No. with + reactions:

0

Total no. in group:

10

Remarks on result:

no indication of skin sensitisation

Reading:

rechallenge

Hours after challenge:

24

Group:

positive control

Dose level:

10% in acetone

No. with + reactions:

8

Total no. in group:

10

Remarks on result:

positive indication of skin sensitisation

Cranial and caudal injection sites: Local irritations were observed in all animals beginning on the day after the injections.

Middle injection sites: 24 hours after induction exposure, no irritative reactions were observed in the negative control group, whereas very slight to severe erythema and oedema were noted in all animals of the test substance group.

All animals had severe erythema and oedema in the interscapular region which were attributed to the effects of the adjuvant.

All animals survived till the end of the study. Intradermal injections of Freund's adjuvant caused severe local reactions in all animals, a known effect of the adjuvant. The test substance affected autonomous nervous system (increased lacrimation) between Days 9 (i.e., after the end of the epicutaneous induction exposure) and 16. No other adverse effects were noted.

Interpretation of results:

GHS criteria not met

Conclusions:

No animal of the test substance group (0/20) was regarded as sensitised. According to the Regulation (EC) 1272/2008 (CLP) the test substance is not considered to cause sensitisation by skin contact.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available