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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, OECD Guideline 402 study, adequate for assessment. However, no data on analytical purity was reported.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MTBE
- Physical state: colourless liquid
- Analytical purity: not reported

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S.p.A.
- Housing: 5 animals/sex/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 45-65
- Air changes (per hr): 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
- fur was clipped from the skin (not abraded)
- exposure area: 6x5 cm of the body dorsal surface
- the test article was applied uniformely by gentle inunction onto the cleared area
- the treated area was covered with a non-porous gauze patch fixed to the skin with impermeable, hypoallergic non-irritating tape (occlusive patch)
- the test side was covered in a suitable manner in order to ensure that the animals cannot ingest the test substance
- the test article was used undiluted as supplied by the sponsor at the volume of administration of 2.70 ml/kg, in order to obtain the dose of 2000 mg/kg being the density 0.740 g/ml.
- at the end of the exposure period the residual test substance was wiped off
Duration of exposure:
24 hours with 14 days observation period
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
Observation of clinical signs and mortality:
at 30 minutes, 2, 4 and 6 hours on the first day after the administration (day 1) and then twice a day up to the termination of the observation period (14 days).

Body weight:
twice pre-trail and on days 8 and 15

Gross pathology:
performed on all animals
Statistics:
No statistical analysis was performed (not needed due to the obtained results).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no deaths.
Clinical signs:
No general clinical signs nor behavioural alterations were observed in any treated rat during the observation period.
At the treatment site slight erythema was noted in 4 animals during the first 8 hours after the 24 hours exposure period.
Body weight:
Body weight gain resulted unaffected by treatment.
Gross pathology:
At autopsy at the end of the observation period no appreciable macroscopic findings were evident in any treated rats.

Applicant's summary and conclusion