Registration Dossier
Registration Dossier
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EC number: 205-771-9 | CAS number: 150-78-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 27 feb 2007 to 29 may 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-dimethoxybenzene
- EC Number:
- 205-771-9
- EC Name:
- 1,4-dimethoxybenzene
- Cas Number:
- 150-78-7
- Molecular formula:
- C8H10O2
- IUPAC Name:
- 1,4-dimethoxybenzene
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Harlan Netherlands BV
Kreuzelweg 53
NL-5961 NM Horst / The Netherlands
Postbus 6174
NL-5960 AD Horst / The Netherlands
- Age at study initiation: 11 weeks (male); 11, 12 weeks (females)
- Weight at study initiation: between 2.3 to 3 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 08/07, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 83/06) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contaminants are archived at RCC Ltd.
- Water: Community tap water from Füllinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12. Music was played during the daytime light period.
IN-LIFE DATES: From 27 feb 2007 to 02 mar 2007
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: purified water
- Controls:
- other: the other flank served as control
- Amount / concentration applied:
- Concentration: 0.5 g
Concentration: moistened with purified water (0.5 ml)
pH: 6.84
- VEHICLE: purified water to moisten Paradimethoxybenzene - Duration of treatment / exposure:
- 4 hour(s)
- Observation period:
- 72 hours
- Number of animals:
- 3: 1 male and 2 females
- Details on study design:
- TEST SITE:
- Area of exposure: on left flank
- % coverage: 6.25 cm²
- Type of wrap if used: no data
REMOVAL OF TEST SUBSTANCE:
- Washing: flushed with lukewarm tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according the Commission Directive 2004/73/EC april 29, 2004; and Directive 2001/59/EC, august 2001
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
Any other information on results incl. tables
Table of results:
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/0/0 |
0/0/0 |
24 h |
0/0/0 |
0/0/0 |
48 h |
0/0/0 |
0/0/0 |
72 h |
0/0/0 |
0/0/0 |
Average 24h, 48h, 72h |
0 |
0 |
Reversibility*) |
No effects |
No effects |
Remark: The
animals were not sacrificed. On completion of the observation period
they were re-allocated to the eye irritation study (RCC Study B16086).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this test, the substance is not irritating
- Executive summary:
In a primary dermal irritation study (RCC study number B16075), New Zealand White rabbits (1 male and 2 females) were dermally exposed to 0.5 g of Paradimethoxybenzene moistened with purified water for 4 hours to 6.25 cm² on left flank.
Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 72 hours.
Irritation was scored according to the EU classification criteria.
The scores were 0 for edema and 0 for erythema.
In this study, Paradimethoxybenzene is not a dermal irritant according to the EU classification criteria.
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