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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2 ethylhexan säure
- Physical state: liquid
- Analytical purity: >99 %
- Lot/batch No.: IRAE 105

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF
- Age at study initiation: 7 weeks (males) 9 weeks (females
- Weight at study initiation: 208 +/- 4 g (males); 191 +/- 3 g (females
- Fasting period before study: no
- Housing: single in macrolone cages (Type 3) on wooden bedding
- Diet (e.g. ad libitum): ad libitum Altromin 1234 (Altromin GmbH, Lage/Lippe)
- Water (e.g. ad libitum): tab water ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage:
- Type of wrap if used: alu folie, fixed by tape (Fixomull; Elastoplast; Fa. Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml pure substance (desity 0.9 g/ml)
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation : daily; weighing prior to application on day 7 and day 17 (Study termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not necessary

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
no clinical symptoms besides eshar formation in two females from day 5-day 8
Body weight:
Body weight development was positive
Gross pathology:
no substance related macroscopic findings

Applicant's summary and conclusion