Registration Dossier

Administrative data

Description of key information

The acute  toxicity of the registration substance is of no concern for oral or dermal routes. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-03-04 to 1991 03-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study; well-performed and well-documented
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Preliminary study; for each dose levels of 500, 1000 and 2000 mg/kg bw one male and one female rats were used. No significant effects were found.
Preliminary study:
No effect found
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality found
Clinical signs:
Within 24 hours: increased respiration rate, squatting posture, sunken flanks, stilted and uncordinated gait, decreased spantaenous activity, bristling coat
Body weight:
Not impaired in the observation period of 14 days
Gross pathology:
No effect
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.
Executive summary:

The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
One valid study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
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
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

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
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.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
One valid study

Additional information

Acute oral toxicity

The acute oral toxicity of the registration substance was investigated according to the OECD Guideline 401. At dose of 2000 mg/kg bw no significant effect was found.

Acute dermal toxicity

The assessment was performed by use of read-across approach

a) Justification for the read-across approach using (Tetrapropylensuccinimido)-caproic acid as supporting substance:

The registration substance (Pentapropylensuccinimido)-caproic acid and proposed supporting substance (Tetrapropylensuccinimido)-caproic acid are homologous series of (Polypropylensuccinimido)-caproic acid. The only structural difference is that the alkyl moiety of the registratoin substance is composed of five propylen unit, whereas that of the supporting substance is composed of four propylen unit. The given structural difference is not likely to be associated with significantly deviating acute dermal toxicity, because neither the skin penetration capacity nor the chemical reactivity is likely to be strongly influenced by the given structural difference.

b) Evaluation of the acute dermal toxicity of the registration substance

The read-across supporting substance did not induce any systemic effect in the acute dermal toxicity study. Likewise no significant acute dermal toxicity for the registration substance can be derived. Also the observed low oral acute toxicity of the registration substance is supporting the low acute dermal toxicity.


Justification for selection of acute toxicity – oral endpoint
Guideline study; well-performed and well-documented

Justification for selection of acute toxicity – dermal endpoint
Guideline study; well-performed and well-documented

Justification for classification or non-classification

The acute toxicity of the registration substance is of no concern for oral or dermal routes. No classification is warranted.