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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 31st, 2011 - February 6th, 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Animals are not randomly selected for use in the study
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate)
- Physical state: Solid (Whitish crystalline powder)
- Lot/batch No.: 2/98-G
- Expiration date of the lot/batch: 30th November 2003
- Storage: At room temperature
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Nossan S.r.l., Correzzana (MI), Italy
- Age at study initiation: approximately 6 to 8 weeks
- Weight at study initiation: 176 to 200 grams
- Housing: polycarbonate cages measuring 42x26x18 cm
- Diet: laboratory rodent diet (Altromin MT, Altromin, Lange Str 42, D-3279 Lage, Germany) ad libitum
- Water: drinking water ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Type of coverage:
occlusive
Vehicle:
other: sterile water
Details on dermal exposure:
TEST SITE
- Area of exposure: at least 10% of the total body surface
- Type of wrap if used: gauze dressings

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/Kg bw
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2000 mg/Kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
other: No clinical signs were observed following dosing
Gross pathology:
No abnormalities were found on necropsy of animals on termination of the study.
Interpretation of results:
GHS criteria not met
Conclusions:
The results of this study indicate that the test item, 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate), has no observable toxic effect in the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg.
Executive summary:

The acute toxicity of 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate) was investigated following administration of a single dermal dose to the rat.

A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for a 24 hour period. A 14 day period followed after which all animals were killed and subjected to a necropsy examination.

No mortality occurred following dosing. No clinical signs were observed during the 14 day post-dose observation period.

Changes in body weight were not remarkable.

Necropsy examination revealed no abnormalities.

These results indicate that the test item, 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate), has no observable toxic effect in the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 000 ng/kg bw

Additional information

The acute toxicity of 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate) was investigated following administration of a single dermal dose to the rat.

A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for a 24 hour period. A 14 day period followed after which all animals were killed and subjected to a necropsy examination.

No mortality occurred following dosing. No clinical signs were observed during the 14 day post-dose observation period.

Changes in body weight were not remarkable.

Necropsy examination revealed no abnormalities.

These results indicate that the test item, 2’deoxy-5-ethyl-uridine,3’,5’-bis(4-chlorobenzoate), has no observable toxic effect in the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg.

Justification for classification or non-classification