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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 635-156-4 | CAS number: 109293-98-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-24 to 1995-07-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- Revised Edition November 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: BUEHLER, E.V. (1965), Delayed contact hypersensitivity in the Guinea-pig. Arch. Dermatol., 91, 171.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Huntingdon Research Centre Ltd.
- Type of study:
- Buehler test
Test material
- Reference substance name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- EC Number:
- 635-156-4
- Cas Number:
- 109293-98-3
- Molecular formula:
- C15 H12 F2 N4 O3 .Na
- IUPAC Name:
- sodium 2-{N-[(3,5-difluorophenyl)carbamoyl]ethanehydrazonoyl}nicotinate
- Reference substance name:
- Diflufenzopyr sodium salt
- IUPAC Name:
- Diflufenzopyr sodium salt
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 282 to 342 g
- Housing: In groups of five in suspended metal cages with wire mesh floors
- Diet: Vitamin C enriched guinea-pig diet FD2 (ad libitum)
- Water: Drinking water (ad libitum)
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 °C
- Humidity: 30 - 70%
- Air changes: 15 air changes per hour
- Photoperiod: 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D: Product of coconut oil, supplied by Alembic Products, Saltney, Chester, England
- Concentration / amount:
- Induction - 50% w/v in Alembicol D
Challenge - 50% w/v in Alembicol D
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- coconut oil
- Remarks:
- Alembicol D: Product of coconut oil, supplied by Alembic Products, Saltney, Chester, England
- Concentration / amount:
- Induction - 50% w/v in Alembicol D
Challenge - 50% w/v in Alembicol D
- No. of animals per dose:
- 20
- Details on study design:
- Preliminary study
The topical irritancy of a range of dilutions of the test substance was investigated to identify where possible (a) concentrations that would produce irritation suitable for the induction phase of the main study and (b) a maximum non-irritant concentration for the challenge phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 (epicutaneous)
- Exposure period: 6 hours (application) // 30 min, 24 hrs (observation)
- Test groups: All
- Control group: Yes
- Site: skin on the left shoulder
- Frequency of applications: Total 9 (three per week)
- Duration: 3 weeks
- Concentrations: 50% w/v in Alembicol D
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day(s) of challenge: 2 weeks after the final induction
- Exposure period: 6 hours (application)
- Test groups: All
- Control group: Yes
- Site: right flank
- Concentrations: 50% w/v in Alembicol D
- Evaluation (hr after challenge): 24, 48, 72 hours after removal of the patches - Challenge controls:
- Yes, the control animals were challenged topically two weeks after the final induction application using the read across substance 50% w/v in coconut oil.
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde (HCA)
Results and discussion
- Positive control results:
- CLINICAL SIGNS
No signs of ill health or toxicity were recorded.
BODYWEIGHT
Bodyweight increases were recorded for all guinea-pigs over the period of the study.
INDUCTION
There were no dermal reactions seen for any of the control animals receiving the dry patch. Irritation generally well-defined was seen for test animals during induction.
CHALLENGE
Six of the ten animals showed evidence of skin sensitisation (delayed contact hypersensitivity), thus confirming the sensitivity of the test method
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- In one animal signs of erythema was observed and in another animal the effects were inconclusive. In 18 animals no signs of ill health or toxicity were recorded.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: In one animal signs of erythema was observed and in another animal the effects were inconclusive. In 18 animals no signs of ill health or toxicity were recorded. .
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50 % w/v
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- In one animal signs of erythema was observed. In the other test animals no signs of ill health or toxicity were recorded.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50 % w/v. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: In one animal signs of erythema was observed. In the other test animals no signs of ill health or toxicity were recorded..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- other: control group
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No signs of ill health or toxicity were recorded.
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: other: control group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No signs of ill health or toxicity were recorded..
Any other information on results incl. tables
CLINICAL SIGNS
No signs of ill health or toxicity were recorded.
BODYWEIGHT
Bodyweight increases were recorded for all guinea-pigs over the period of the study.
INDUCTION
There were no dermal reactions seen in any of the test or control animals.
CHALLENGE
The dermal reaction seen for one of the twenty test animals (slight irritation) was more marked than those seen for the controls and therefore this animal was given a positive response. A further one animal gave an inconclusive response. The remaining eighteen test animals (no irritation) were same as those seen for control animals and these animals were therefore given a negative response.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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.
