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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep - Nov 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Limit test:
yes

Test material

Constituent 1
Reference substance name:
FEXO-07
IUPAC Name:
FEXO-07
Test material form:
other: crystalline powder
Details on test material:
Description: white/apparently white crystalline powder.
Purity/Formulation: >99%.
Stability of test item: stable under storage conditions.
Stability of test item dilution: unknown in PEG 300 (Polyethylene glycol 300).
Storage conditions: at room temperature (range of 20 ± 5 °C), light protected.
Safety precautions: routine hygienic procedures were used to ensure the health and safety of the personnel.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST SYSTEM
Age when treated: Males: 8 weeks; Females: 11 weeks
ldentification: by unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: selected by hand at lime of delivery. No computer generated randomization program.
Acclimatization: under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

HUSBANDRY
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70% (values above 70% during cleaning process possible), automatically controlled, light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: during acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. lndividually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation.
Diet: pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 36106 (Provimi Kliba AG, CH-4303 Kaiseraugstl Switzerland) ad libitum. Results of analyses for contaminants are archived at the test facility.
Water: community tap water ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at the test facility.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
polyethylene glycol
Remarks:
Colorless viscous liquid, stable under storage conditions.
Details on dermal exposure:
FEXO-07 was applied undiluted as delivered from the sponsor.
Duration of exposure:
The application period was 24 hours.
Doses:
2000 mg/kg body weight
The test item was diluted in vehicle (PEG 300) at a concentration of 0.33 g/ml and administered at a volume dosage of 6 ml/kg.
No. of animals per sex per dose:
Number of animals per group: 5 males and 5 females.
Total number of animals: 5 males and 5 females.
Control animals:
not specified
Details on study design:
The purpose of this study was to assess the acute dermal toxicity of Fexo-07 when administered to rats by a single semi-occlusive dermal application, followed by an observation period of 14 days.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of Fexo-07 after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): > 2000 mg/kg body weight.
Executive summary:

Five male and five female HanRcc:WIST (SPF) rats were treated with Fexo-07 at 2000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.33 g/mL and administered at a volume dosage of 6 mL/kg.

The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2 -15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2 -15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.

All animals were necropsied and examined macroscopically. No deaths occurred during the study. No clinical signs of toxicity or local dermal findings were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy.