Registration Dossier
Registration Dossier
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EC number: 612-975-5 | CAS number: 6225-08-7
Endpoint summary
Administrative data
Description of key information
The skin sensitization property of the registration substance was investigated according to the Guideline OECD 406 (Guinea Pig Maximization Test). The registration substance was found to be a non-skin sensitizer.
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:
- 27 May 2017 to 18 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Section 4, Number 406, “Skin Sensitisation”, adopted on 17 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The registration substance os a surfactant.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch No.of test material: 112-2016-11 D
- Expiration date of the batch: May 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Cool and dry (+2 to +8°C)
FORM AS APPLIED IN THE TEST: Liquid - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Jeeva Life Sciences
- Age at study initiation: Pre Study : 10 to 11 weeks
Main Study : 9 weeks
- Weight at study initiation: Pre Study : 320.82 g to 336.94 g
Main Study : 329.84 g to 352.58 g
- Housing: Animals were housed individually in a standard polypropylene cage (size: L 430 x B 285 x H 150 mm)
- Diet (e.g. ad libitum): Altromin maintenance diet for guinea pigs (manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to ultraviolet rays in Aquaguard water filter with purifier
- Acclimation period: Pre Study: 30 May 2017 to 04 June 2017
Main Study: 10 June 2017 to 14 June 2017
- Indication of any skin lesions: No
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.3°C to 22.9°C
- Humidity (%): 44% to 65%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
- IN-LIFE DATES: Pre Study: From: 05 June 2017 To: 08 June 2017
Main Study: From: 15 June 2017 To: 10 July 2017 - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.5% for intradermal
100% for epicutaneous - Day(s)/duration:
- intradermal induction on day 1, epicutaneous induction on day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- on day 21 / 24h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- The study included a pre-study, in which total four animals were used.
- Positive control substance(s):
- no
- Remarks:
- The positive control has not been included in this study as the reliability of the skin sensitization was tested using 2-Mercapto benzothiazole as apart of study No.: BIO-TX 2468
- Positive control results:
- The positive control has not been included in this study as the reliability of the skin sensitization was tested using 2-Mercapto benzothiazole as apart of study No.: BIO-TX 2468
- Group:
- positive control
- Remarks on result:
- other: no report for the positive control
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitization property of the registration substance was investigated according to the Guideline OECD 406 (Guinea Pig Maximization Test). The registration substance was found to be a non-skin sensitizer.
- Executive summary:
The registration substance ,Genagen PA/N,N-Dimethylanonanamide was evaluated for the skin sensitization potential in Guinea pigs as per theOECD Guideline for Testing of Chemicals, Section 4, Number 406, “Skin Sensitization”.
The study was conducted in two phase viz., pre-study and main study.
In the pre-study two animals were intradermally treated, each at two sites, at concentration of 0.5, 1.0, 2.5 and 5% in propylene glycol. Severe to slight erythema was found in dose-response manner. Two animals were treated topically, each at two sites, at concentration of 25, 50, 75 and 100% in ethanol/water. No response was found up to the highest concentration.
In the main study the intradermal induction at concentration of 0.5% in propylene glycol on day 1 and the topical induction at concentration of 100% on day 8 was conducted. The corresponding control animals were treated with vehicles only. On day 21 the treated and the control animals were treated topically at concentration of 100% for 24h.
None of the treated and control animals responded upon the challenge.
The registration substance is found to be a non-skin sensitizer.
Reference
TABLE 1. SKIN REACTION SCORING RECORD DURING PRE- STUDY
Group, Sex & Treatment |
Site of Treatment |
Animal No. |
Test Concentration |
24hour* |
48hour* |
|||
Ery |
Ede |
Ery |
Ede |
|||||
G1, Male & Genagen PA/N,N-Dimethylnonanamide |
Intradermal Application |
Site 1 |
Ga8341 |
0.5% v/v Test Item in propylene glycol |
0 |
0 |
1 |
0 |
Site 2 |
1.0% v/v Test Item in propylene glycol |
1 |
0 |
2 |
0 |
|||
Site 1 |
Ga8342 |
2.5% v/v Test Item in propylene glycol |
2 |
0 |
3 |
0 |
||
Site 2 |
5% v/v Test Item in propylene glycol |
2 |
0 |
3 |
0 |
|||
Topical application |
Left Flank |
Ga8343 |
25 % v/v Test Item in80% ethanol/water |
0 |
0 |
0 |
0 |
|
Right Flank |
50 % v/v Test Item in80% ethanol/water |
0 |
0 |
0 |
0 |
|||
Left Flank |
Ga8344
|
75 % v/v Test Item in80% ethanol/water |
0 |
0 |
0 |
0 |
||
Right Flank |
Undiluted Test Item |
0 |
0 |
0 |
0 |
|||
Ery: Erythema; Ede: Oedema; hr: Hour; *: Observation time points after intradermal injection and after patch removal.
TABLE 2. SKIN REACTION SCORING RECORD DURING MAIN STUDY
Group, Sex & Treatment |
Animal No. |
Intradermal Induction (Day 1) |
Topical Induction (Day 8) |
Challenge (Day 22) |
||||||||||
Site |
24 hours |
48 hours |
1 hour |
24 hours |
24 hours |
48 hours |
||||||||
Ery |
Ede |
Ery |
Ede |
Ery |
Ede |
Ery |
Ede |
RF |
RF |
RF |
RF |
|||
Ant |
Post |
Ant |
Post |
|||||||||||
G2, Male & Vehicle control |
Ga8345 |
1 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8346 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8347 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8348 |
1 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||||||||||
3 |
2 |
1 |
1 |
1 |
||||||||||
Ga8349 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||||||||||
3 |
2 |
1 |
1 |
1 |
||||||||||
G3, Male & Genagen PA/N,N-Dimethylnonanamide |
Ga8350 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8351 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8352 |
1 |
2 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
1 |
2 |
||||||||||
Ga8353 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8354 |
1 |
2 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
2 |
1 |
1 |
1 |
||||||||||
Ga8355 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8356 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
2 |
1 |
1 |
1 |
||||||||||
Ga8357 |
1 |
1 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
1 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
1 |
1 |
||||||||||
Ga8358 |
1 |
2 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
1 |
0 |
||||||||||
3 |
1 |
1 |
2 |
1 |
||||||||||
Ga8359 |
1 |
2 |
1 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
||||||||||
3 |
2 |
1 |
2 |
1 |
||||||||||
Ery: Erythema, Ede: Oedema, RF: Right flank; Ant: Anterior Part; Post: Posterior Part
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The registration substance ,Genagen PA/N,N- was evaluated for the skin sensitization potential in Guinea pigs as per theOECD Guideline for Testing of Chemicals, Section 4, Number 406, “Skin Sensitization”.
The study was conducted in two phase viz., pre-study and main study.
In the pre-study two animals were intradermally treated, each at two sites, at concentration of 0.5, 1.0, 2.5 and 5% in propylene glycol. Severe to slight erythema was found in dose-response manner. Two animals were treated topically, each at two sites, at concentration of 25, 50, 75 and 100% in ethanol/water. No response was found up to the highest concentration.
In the main study the intradermal induction at concentration of 0.5% in propylene glycol on day 1 and the topical induction at concentration of 100% on day 8 was conducted. The corresponding control animals were treated with vehicles only. On day 21 the treated and the control animals were treated topically at concentration of 100% for 24h.
None of the treated and control animals responded upon the challenge.
The registration substance is found to be a non-skin sensitizer.
Justification for classification or non-classification
The skin sensitization property of the registration substance was investigated according to the Guideline OECD 406 (Guinea Pig Maximization Test). The registration substance was found to be a non-skin sensitizer. No classification is justified.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
