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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-354-4 | CAS number: 330-54-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Apr 1997 - 06 Jun 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.
Test material
- Reference substance name:
- Diuron
- EC Number:
- 206-354-4
- EC Name:
- Diuron
- Cas Number:
- 330-54-1
- Molecular formula:
- C9H10Cl2N2O
- IUPAC Name:
- 3-(3,4-dichlorophenyl)-1,1-dimethylurea
- Details on test material:
- - Physical state: white powder
- Analytical purity: 99.2%
- Lot/batch No.: 212/02/96
- Expiration date of the lot/batch: 1998-02-12
- Stability under test conditions: substance is stable at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Biocon Research, Pretoria, South Africa
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: pre-test (male): 434 - 532 g; main test (female): 302 - 503 g
- Housing: conventionally, 5 animals per cage (standard fibre glass)
- Diet: food ad libitum, supplemented with lettuce leaves once weekly
- Water: water ad libitum, supplemeted with Vitamin C
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21
- Humidity (%): 43 - 70
- Air changes (per hr): approx. 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- a) first induction intradermally: 10% solution in physiological saline
b) second induction epicutaneously: 50% solution in physiological saline
c) for challenge epicutaneously: 50% solution in physiological saline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- a) first induction intradermally: 10% solution in physiological saline
b) second induction epicutaneously: 50% solution in physiological saline
c) for challenge epicutaneously: 50% solution in physiological saline
- No. of animals per dose:
- test group: 20
pre-test: 6 - Details on study design:
- RANGE FINDING TESTS:
Dermal irritations (erythema/oedema) were investigated using different concentrations.
A 10 % solution of Diuron in saline, as the highest dose not causing local necrosis, ulceration or systemic toxicity was selected for intradermal
induction. For topical induction, a 50 % solution was selected, the highest concentration that did not produce irritation.
The maximum non-irritant concentration for challenge was 50 % Diuron in saline.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups:
Day 0: Three pairs of injections (2 x 0.1 mL):
Freund’s complete adjuvant with physiological saline (50:50) and the test substance (10% in physiological saline)
close to the first two injections, both close to the head
the test substance (10%) in a mixture Freund’s complete adjuvant with physiological saline (50:50), towards the caudal part of the test area.
Day 7: epicutaneous administration of the test article. The test substance was held in contact with the skin under an occlusive patch for 48 hours.
- Control group: The control group was treated similarly, receiving vehicle only.
- Site: scapular region, 4 x 6 cm2
- Concentrations: 10% test substance in saline and 50% test substance in petrolatum,
0.1% Freund’s complete adjuvant in an equal volume physiological saline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Exposure period: The test substance was held in contact with the skin under an occlusive patch for 24 hours and was removed with sterile water
afterwards
- Site: flanks
- Concentrations: 50% in physiological saline (maximum non-irritant concentration)
- Evaluation (hr after challenge): 48h and 72h after challenge
OTHER:
- Clinical signs and body weights were recorded.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- 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:
- 72
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Results of the test study:
All guinea-pigs survived the study. Body weights were comparable between the two groups.
No erythema or oedema was observed in any of the animals challenged with Diuron.
It is concluded that the test item did not provoke skin sensitization at a 50% concentration in guinea pigs.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Executive summary:
A reliable GPMT test was conducted in compliance with OECD Guideline 406. Female guinea-pigs were intradermally and epicutaneously induced before being challenged with a 50% Diuron solution in saline. No skin reaction on the basis of erythema and oedema (sensitization rate 0%) was observed. A 50% solution of Diuron did not provoke skin sensitization (Sharp 1997).
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.
