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EC number: 454-790-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test item showed no positive responders in a study according to OECD Guideline 406 and is not considered to be sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 02- Sep 26, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was performed before enforcement of the OECD guideline for LLNA.
- Species:
- other: guinea pig HsdPoc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Age at study initiation: about 5 weeks
- Weight at study initiation: 323 g (range from 296 to 367 g).
- Housing: Two guinea pigs were housed in type IV Makrolon cages with a shelter and placed on mobile racks.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24°C
- Humidity (%): 45 to 74 %
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12 / 12 h
IN-LIFE DATES: From: day 1 To: day 25 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 50 g/L
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 200 g/L
- Day(s)/duration:
- Day 8/ 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 g/L
- Day(s)/duration:
- Day 22/ 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Pre test: 5 (f)
Number of animals in negative control group: 5 (f)
Number of animals in test material group: 10 (f) - Details on study design:
- + ++ +++
I . . . . . . . I . . . . . . . . . . . . . l . . I
1 8 22 25 day of experimental part
Induction: stage I + intradermal injection
stage II ++ topical application
Challenge: +++ topical challenge
Positive control data have been taken from another GLP study. - Positive control substance(s):
- yes
- Remarks:
- 2-Hexylcinnamaldehyde
- Positive control results:
- Positive Reactions:
Vehicle 48h: 0/10
Vehicle 72h: 0/10
Test material 48h: 5/10
Test material 72h: 3/10
Overall:
Vehicle: 0%
Test material: 50% - Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs were observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs were observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no clinical signs were observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no clinical signs were observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 78
- Group:
- positive control
- Dose level:
- 10 g/L
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After challenge no positive reactions in the test material treated skin sites at both readings were seen. Thus, the test item showed no positive responders and is not considered to be sensitizing to skin.
- Executive summary:
Study design
The test material was evaluated for skin sensitizing properties in. the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969).
5 Female guinea pigs in the negative control group (group 1) treated with the vehicles (liquid paraffin and ethylene glycol 400) and 10 females in the test material group (group 2) were investigated.
Induction included intradermal injection of test material preparation in liquid paraffin (50 g/L with and without Freund's complete adjuvant) on day 1, and topical application of test material preparation in propylene glycol for 48 hours (200 g/L) starting on experimental day 8.
Challenge by topical application of test material preparation in propylene glycol for 24 hours (50 g/L) was performed two weeks after topical induction. Readings were taken at 48 and 72 hours.
Results
Reaction after challenge
Induction with
test materialchallenged with
test materialpositive / total animals
positive / total animals
48 h 72 h overall 50 g/L i.d.; 200 g/L topical 50 g/L 0 / 10 0 / 10 0 / 10
After challenge no positive reactions were observed in the test material treated skin sites.
Conclusions
In conclusion, the test item showed no positive responders and is not considered to be sensitizing to skin.
Reference
Group 1: negative control group
After challenge with polyethylene glycol 400, no erythema or edema were observed at the readings. A single treatment was performed with the test material (50 g/L polyethylene glycol 400) to exclude primary irritation of the test material concentration. No positive reactions were observed in the treated areas at any reading.
Group 2: test material group
After challenge with the test material (50 g/L preparation in polyethylene glycol 400) no positive skin reactions were observed at the readings. This results in 0 % positive reactions after challenge.
After challenge, no positive reactions were observed in the areas treated with polyethyleneglycol 400 alone at any reading.
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
Based on the data provided which are considered to be reliable and suitable for classification, the test item is not classified for skin sensitization according to Regulation (EC) No 1272/2008.
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