Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 946-945-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Feb - Sep 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP / guideline study with no deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study had been performed prior to REACH and focussing on use in jurisdictions that had not acknowledged the OECD LLNA test-protocol at that time; thus, the OECD 406 protocol had been used.
Test material
- Reference substance name:
- d-Phenothrin
- IUPAC Name:
- d-Phenothrin
- Reference substance name:
- Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)
- IUPAC Name:
- Cyclopropanecarboxylic acid, 2,2-dimethyl-3-(2-methyl-1-propenyl)-, (3-phenoxyphenyl) methyl ester, (1R)
- Reference substance name:
- 188023-86-1
- Cas Number:
- 188023-86-1
- IUPAC Name:
- 188023-86-1
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): d-Phenothrin
- Physical state: yellow to brown transparent viscous liquid
- Purity test date: 25 August 2005
- Lot/batch No.: S5237276801
- Expiration date of the lot/batch: July 2008
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: m: 402 - 562 g; f: 298 - 365 g
- Housing: 2-3 animals per stainless steel wire meshed cage
- Diet (e.g. ad libitum): guinea pig pellet feed ad libitum
- Water (e.g. ad libitum): charcoal filtered and UV sterilised tap water, supplemented vith 1 g vitamin C / L, ad libitum
- Acclimation period: 6 - 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 64 - 66
- Air changes (per hr): min. 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2006-06-02 To: 2006-06-26
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Intradermal induction: 5% in propylene glycol
Epicutaneous induction: 100%
Challenge: 100%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Intradermal induction: 5% in propylene glycol
Epicutaneous induction: 100%
Challenge: 100%
- No. of animals per dose:
- Control: 10
Test substance: 20 - Details on study design:
- RANGE FINDING TESTS: 4 animals each were used for intradermal and epicutaneous pre-tests
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal+topical)
- Exposure period: Day 0 (intradermal), Day 7 (topical)
- Site: intrascapular (intradermal), left flank (topical)
- Frequency of applications: single
- Duration: 48 h
- Concentrations: 5% (intradermal, 0.1 mL), 100% (topical, 0.2 mL)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 21
- Exposure period: 24 h
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24+48 h after patch removal - Challenge controls:
- Control guinea pigs that had received a sham induction with 80% ethanol were challenged with 100% test substance.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- 50% and 40% of guinea pigs induced with 2-MBT exhibited a positive response after 24 and 48 h, respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical signs.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- not reported
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: not reported. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- not reported
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Clinical observations:
- no clinical signs
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: not reported. No with. + reactions: 8.0. Total no. in groups: 20.0. Clinical observations: no clinical signs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance d-Phenothrin is not a skin sensitizer according to the criteria of Regulation 1272/2008 in this study.
- Executive summary:
This study was conducted to assess the skin sensitisation potential of d-Phenothrin in guinea pigs. The method followed was as per the guidelines of OECD No 406 (July 1992) using the Guinea-pig Maximisation Test Method.
Thirty Hartley strain guinea pigs were randomly divided into two groups. The control group comprised of 10 guinea pigs (5 males and 5 females) and the treatment group comprised of 20 guinea pigs (10 males and 10 females). Based on the results of the pilot study, 5.0% (v/v) d-Phenothrin in propylene glycol was selected for intradermal injection during induction exposure on day 0. Since d-Phenothrin was found to be non-irritant, the clipped site was painted with 0.5 mL of 10% sodium lauryl sulphate in vaseline to augment local skin irritation. Undiluted d-Phenothrin (0.2 mL) was selected for topical application during induction (on day 7) and challenge exposure (on day 21).
The skin reactions of the guinea pigs were recorded post induction (intradermal injections/topical application) following the Draize method (Draize et al., 1944) and at 24 and 48 h post challenge treatment following the Magnusson and Kligman grading scale (Magnusson and Kligman, 1969).
Very slight erythema (in 7/20 guinea pigs) to well-defined erythema (in 13/20 guinea pigs) and very slight oedema (in 19/20 guinea pigs) were observed on day 1 in the guinea pigs from the treatment group following intradermal injection (day 0). Very slight erythema (in 11/20 guinea pigs) to well-defined erythema (in 9/20 guinea pigs) and very slight oedema (in 8/20 huinea pigs) were observed on day 10 on the left flank of the treatment group guinea pigs following topical application on day 7. No skin reactions were observed in the guinea pigs from the control group.
Visual observation of the skin following challenge exposure did not reveal any positive skin response at 24 or 48 h post patch removal in the guinea pigs belonging to the treatment group.
No clinical signs related to treatment other than skin irritation were observed during the course of the study.
The mean body weights of the treatment group guinea pigs remained comparable to those of the control group.
A sensitisation rate of zero percent at 24 and 48 h post patch removal was observed, using an adjuvant.
As a result, d-Phenothrin is not considered a skin sensitiser in this study.
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.
