Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-02-04 to 1988-02-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP and guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP compliance statement attached to full study report.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
- Strain: Hoe: WISKf(SPF71)
- Source: Hoechst AG, kastengrund, SPF breed
- Weight at study initiation:
male: mean = 207 +/- 4 g (min: 202 g, max: 211 g)
female: mean = 204 +/- 4 g (min: 200 g, max: 209 g)
- Age at study initiation: male and females: approx. 9 weeks
- Randomisation according to procedure Nr. 36/88 and 61/88
- Housing: single cages in air conditioned rooms
- Temperature: 22 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Lighting: 12 hrs daily
- Acclimatisation period: min 5 days
- Diet: rat diet Altromin 1324, ad libitum
- Water: tap water, ad libitum
- Identification: numbering of cages

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Details on dermal exposure:
- Shaved area: 30 cm^2 mechanically depilated
- Exposed area:the test item with vehicle was spread on an aluminium foil of 6x8 cm
- After 24 hrs of exposure washing with luke warm water
Duration of exposure:
24 hrs
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Observation time: 14 days
- Weekly weighting of animals
- Sacrifice and necropsy of animals after observation time.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None.
Clinical signs:
None.
Body weight:
No impact on development of body weight observed.
Gross pathology:
None.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

1-chloro-2,5-dimethoxy-4-nitrobenzene was tested for its acute dermal toxicity using male and female Wistar rats. After application of a dose of 2000 mg/kg body weight (the limit dose specified in OECD 402) no mortalities or any clinical signs were observed. Necropsy after sacrifice did not reveal any macroscopically visible changes. According to classification criteria as laid down in 83/467(EEC 1-chloro-2,5-dimethoxy-4-nitrobenzene is not classified.