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:
2011-05-05 to 2011-05-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Rationale for reliability of 2: Guideline study, well-performed and well-documented, read-across Justification of read-across: the registration substance and the read-across supporting substance belong to homolog series of (Polypropylensuccinimido)-caproic acid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
gas under pressure: refrigerated liquefied gas
Details on test material:
Batch Nr: ESD0009058

Test animals

Species:
rat
Strain:
other: RccHanTM: WIST(SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories B.V.
- Age at study initiation: 9 or 11 weeks
- Weight at study initiation: 183.8 g – 193.5 g (females); 228.2 g – 245.7g (males)
- Fasting period before study:
- Housing: Standard Laboratory Conditions.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Six days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 5 cm
- % coverage: 10% of the total body surface
- Type of wrap if used: surgical gauze pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hour application period, the dressing was removed and the skin was flushed with
lukewarm water and drapped off with disposable paper towels.
- Time after start of exposure: 24-hour

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg
- Concentration (if solution): 2000 mg/kg
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg
- Lot/batch no. (if required): 400 159 216
Duration of exposure:
24 Hour
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Daily during acclimatization. Once before treatment and within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on test day 1 (in common with the clinical signs). Twice daily during test days 2 – 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination
Statistics:
No statistical analysis was performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No intercurrent deaths occurred during the course of the study.
Clinical signs:
No clinical signs were observed throughout the entire observation period.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were recorded at necropsy.
Other findings:
All animals showed slight erythema from the beginning of the observation until days three or five and six. Additionally, all animals had slight focal crusts and slight desquamation on several days, in most cases during the six last days of the observation period.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The median lethal dose of (Tetrapropylenesuccinimido)-caproic acid after single dermal administration to male and female rats, observed over a period of 14 days, is: LD50(dermal) (Wistar rat): greater than 2000 mg/kg body weight
Executive summary:

The acute dermal toxicity of the registration substance was assessed based on the read-across approach using (Tetrapropylensuccinimido)-caproic acid as read-across supporting substance.

The acute dermal toxicity of (Tetrapropylensuccinimido)-caproic acid was investigated according to the OECD Guideline 402. At dose level of 2000 mg/kg bw no systemic effect was observed.