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Toxicological information

Skin irritation / corrosion

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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:
other: The study was GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
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

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: 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.