Formaldehyde, polymer with benzenamine, hydrogenated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-02-14 to 2005-03-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(2004)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine

EC Number:

603-894-6

Cas Number:

135108-88-2

Molecular formula:

Exact identification is not feasible

IUPAC Name:

2,4-bis[(4-aminocyclohexyl)methyl]aniline; 2,4-bis[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 2-[(1-aminocyclohexyl)methyl]aniline; 4-[(4-aminocyclohexyl)methyl]cyclohexan-1-amine; 4-{[4-({4-[(4-aminocyclohexyl)methyl]cyclohexyl}amino)cyclohexyl]methyl}cyclohexan-1-amine

Test material form:

liquid: viscous

Details on test material:

Copolymer of aniline and formaldehyde, hydrogenated of Degussa AG, batch no. 923-050110 of 10 Jan. 2005.

Test animals

Species:

rat

Strain:

other: White Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS: 
- Source: White WISTAR, Harlan Winkelmann, Borchen, Germany
- Weight at study initiation: 165.2 - 199.0 g, about 9 weeks
- Fasting period before study: maximum 20 hours
- Diet: Altromin, rat diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 22 °C +/- 3° C
- Humidity (%): 30 % - 70 %
- Air changes (per hr): 8 times
- Illumination: 12 hours artifical fluorescent light and 12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

ADMINISTRATION: 
- Frequency: single dosage on day 1
- Dose: 300 mg/kg/bw (applied as 10 % w/w) and 50 mg/kg bw (applied as 5 % w/w)
- DOSAGE PREPARATION: dispersion in sesame oil
- Starting dose 300 mg/kg bw, next step 50 mg/kg bw

Doses:

300 mg/kg/bw and 50 mg/kg bw

No. of animals per sex per dose:

3 female at 300 mg/kg
6 female at 50 mg/kg

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: periodic intervals on the dayof dosing and once daily thereafter, until day 15
- Body weight: days 1 (pre-administration) 8 and 15
- Necropsy: Animals died ahead of schedule were necropsied immediately, all survived animals were necropsied at the end of the observation period

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 50 - < 300 mg/kg bw

Mortality:

300 mg/kg: 2 of 3 female rats died within 20 minutes after application
50 mg/kg: no mortality

Clinical signs:

other: 300 mg/kg: 2 of 3 female rats showed ataxia, decreased respiration, gasping, side position and convulsion, died within 20 minutes after application 50 mg/kg: no toxic symptoms were observed

Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:

The LD50 cut-off for VESTAMIN EP-HS 10 was estimated to be 300 mg/kg. Ranking of the test substance VESTAMIN EP-HS 10 according to the Global Harmonised System resulted in Category 3: > 50 - 300 mg/kg

Executive summary:

The acute oral toxicity study of VESTAMIN EP-HS 10 was determined with 9 female WISTAR rats. Animals were observed for symptoms of clinical toxicity and mortality for 14 days after treatment. At first 3 female rats were treated with 300 mg/kg bw. Two rats showed ataxia, decreased respiration, gasping, side position and convulsion and died within 20 minutes after application. Necropsy immediatley after the death showed no substance related morphological visible pathologic organ findings. The remaining animal showed no toxic symptoms . After that, 2 groups of 3 female rats were dosed with 50 mg/kg. No toxic symptoms were observed and no death occurred. No apparent changes were found in body weights of remaining rats. All survived animals showed

no substance related morphological visible pathologic organ findings.

The LD50 cut-off for VESTAMIN EP-HS 10 is 300 mg/kg. Ranking of the test substance VESTAMIN EP-HS 10 according to the Global Harmonised System resulted in Category 3: > 50 - 300 mg/kg