Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1998-09-01 to 1998-09-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tri (hexyl, octyl, decyl) citrate
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature in a closed container

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 218 - 250 g
- Housing: individually kept in Macrolon cages on Altromin saw fiber bedding
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1998-09-01 To: 1998-09-16

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: gauze-dressing and non-irritating tape, fixed with an additional dressing to prevent ingestion


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical examination once a day, weighing prior to application and once a week thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no compound related mortality observed
Clinical signs:
All animals showed reduced spontaneous activity throughout the contact period. Activity rose immediately after removal of dressing.
No clinical signs of toxicity were observed throughout the observation period.
Body weight:
A slight weight loss in 3 of 5 female animals were observed. The weight gain of the male animals were in the expected range.
Gross pathology:
No test compound related macroscopic necropsy findings were recorded.
Other findings:
Necropsy revealed an acute injection of blood vessels in all animals in the abdominal region. This finding was subjected to be due to euthanasia with an overdose of pentobarbital injected intraperitoneally.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The application of the test item in a dose of 2000 mg/kg bw caused no compound related mortalities.