Registration Dossier
Registration Dossier
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EC number: 221-022-9 | CAS number: 2976-74-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study had been performed in accordance with OECD Guideline No.:406.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2006
Materials and methods
Test guideline
- 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:
- The studies were carried out in 2010.
Test material
- Reference substance name:
- 2,3-dichlorophenoxyacetic acid
- EC Number:
- 221-022-9
- EC Name:
- 2,3-dichlorophenoxyacetic acid
- Cas Number:
- 2976-74-1
- Molecular formula:
- C8H6Cl2O3
- IUPAC Name:
- (2,3-dichlorophenoxy)acetic acid
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Dichlorophenoxyacetic acid
- Physical state: light beige powder
- Purity test date: 26. 09. 2005
- Lot/batch No.: 10
- Expiration date of the lot/batch: : 07. 2006
- Storage condition of test material: at room temperature, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: LAB-ÁLL Bt , Hunyadi 7, Budapest, H-1174, Hungary
- Weight at study initiation: 320-350 g
- Housing: Macrolon cage, size III (42x42x19 cm), 2-3 animals / cage
- Bedding: Laboratory bedding, SSNIFF Lignocel 3-4 Fasem
- Diet (e.g. ad libitum): ad libitum (PURINA Base - Lap gr. diet for rabbits produced by AGRIBANDS Europe Hungary)
- Water (e.g. ad libitum): ad libitum, tap water for human consumption containing 50 mg / 100 ml Ascorbic acid
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 / 12 hours
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 1% Methylcellulose
- Concentration / amount:
- 50 (w/v) % (test item in methyl cellulose (1%) for dermal treatment and for challange treatment
1 (w/v) % (in physiological saline and Freund's complete adjuvant ) for intradermal treatment
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% Methylcellulose
- Concentration / amount:
- 50 (w/v) % (test item in methyl cellulose (1%) for dermal treatment and for challange treatment
1 (w/v) % (in physiological saline and Freund's complete adjuvant ) for intradermal treatment
- No. of animals per dose:
- 10 animals (in test groups)
5 animals (in control groups) - Details on study design:
- RANGE FINDING TESTS: three dose levels was tested in the preliminary dose range finding study to identify any primary irritation by intra-dermal injection and three dose levels were tested by dermal application.
Further information about treatments see under paragraph 'any other information...'
Results and discussion
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:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no visible change
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
It has not been detected any sign of contact sensitisation in guinea pigs exposed previously to the test item during experiments.
In the control and treated animals the mean of the scores was 0.00 according to the 24th and 48th-hour results.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the net percentage value of positively responded animals and to the net score value of the skin reactions, the test item DICHLOROPHENOXYACETIC ACID was classified as a non-sensitiser.
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