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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 March 2014 to 5 June 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Reaction Products of N-(2-aminoethyl)-N’-{2-[(2-aminoethyl)amino]ethyl}ethane-1,2-diamine, N-(2-aminoethyl)-N’-[2-(piperazin-1-yl)ethyl]ethane-1,2-diamine,N-{2-[4-(2-aminoethyl)piperazin-1-yl]ethyl}ethane-1,2-diamine,N,N,N’-tris(2-aminoethyl) ethane-1,2-diamine, carbon disulphide and sodium hydroxide.
IUPAC Name:
Reaction Products of N-(2-aminoethyl)-N’-{2-[(2-aminoethyl)amino]ethyl}ethane-1,2-diamine, N-(2-aminoethyl)-N’-[2-(piperazin-1-yl)ethyl]ethane-1,2-diamine,N-{2-[4-(2-aminoethyl)piperazin-1-yl]ethyl}ethane-1,2-diamine,N,N,N’-tris(2-aminoethyl) ethane-1,2-diamine, carbon disulphide and sodium hydroxide.
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Reaction Products of N-(2-aminoethyl)-N’-{2-[(2-aminoethyl)amino]ethyl}ethane-1,2-diamine, N-(2-aminoethyl)-N’-[2-(piperazin-1-yl)ethyl]ethane-1,2-diamine,N-{2-[4-(2-aminoethyl)piperazin-1-yl]ethyl}ethane-1,2-diamine,N,N,N’-tris(2-aminoethyl) ethane-1,2-diamine, carbon disulphide and sodium hydroxide - EC 939-782-1
- Physical state: Brown liquid
- Analytical purity: 40.5%
- Lot/batch No.: 311045D
- Expiration date of the lot/batch: 22nd November 2014
- Storage condition of test material: Room temperature (in original container) tightly closed in well-ventilated spaces

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Animal Breeding Facility, JRF
- Age at study initiation: 9-15 weeks
- Weight at study initiation (g): Males: Min. 281.3 and Max. 297.8; Females: Min. 234.7 and Max. 249.6
- Housing: Polypropylene rat cages with stainless steel grid tops. Bedding was autoclaved clean rice husk. Rats were group-housed during acclimatisation, and individually housed following test item application. After patch removal following 24 hrs exposure, rats were housed 2 to 3 rats/cage, according to group and sex. Animal room was cleaned daily.
- Diet (e.g. ad libitum): Teklad certified Global High Fiber Rat/Mice Feed manufactured by Harlan, U.S.A.
- Water (e.g. ad libitum): UV sterilized water filtered through Kent Reverse Osmosis water filtration system.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 65 to 67 (relative humidity)
- Air changes (per hr): Minimum 15
- Photoperiod (hrs dark / hrs light): 12/12 (light hours: 06:00 h - 18:00 h)

IN-LIFE DATES: From: 20 March 2014 to 10 April 2014

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Approximately 7x5 cm body surface area
- % coverage: >10% body surface was clipped 24 hours prior to test substance application
-Type of wrap: Porous gauze dressing and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed using cotton soaked in distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2000 mg/kg body weight (undiluted)
Duration of exposure:
24 hour
Doses:
Limit dose of 2000 mg/kg body weight (undiluted)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Toxicity and mortality were observed 1, 2, 3 and 5h post-dermal application on day 0. Morbidity and mortality were observed twice daily for 14 days
- Clinical signs were recorded once daily
- Individual body weight: Prior to dermal application on day 0 and on days 7 and 14 post-application.
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Erythema was observed in a single male and all females
Body weight:
No biologically relevant body weight change observed
Gross pathology:
- Necropsy (Macroscopic Findings): External examination of male and female rats revealed no abnormality of pathological significance. Internal visceral examination of male and female rats reveal no abnormal lesions.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal median lethal dose, LD50 of reaction products of N-(2-aminoethyl)-N’-{2-[(2-aminoethyl)amino]ethyl}ethane-1,2-diamine, N-(2-aminoethyl)-N’-[2-(piperazin-1-yl)ethyl]ethane-1,2-diamine,N-{2-[4-(2-aminoethyl)piperazin-1-yl]ethyl}ethane-1,2-diamine,N,N,N’-tris(2-aminoethyl) ethane-1,2-diamine, carbon disulphide and sodium hydroxide in Wistar rats was found to be greater than 2000 mg/kg body weight.

Based on the results, an indication of the classification is Category 5 or Unclassified.

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