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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Cyclohex-1,2-ylenediamine
EC Number:
211-776-7
EC Name:
Cyclohex-1,2-ylenediamine
Cas Number:
694-83-7
Molecular formula:
C6H14N2
IUPAC Name:
cyclohexane-1,2-diamine
Details on test material:
- Name of test material (as cited in study report): HEXAMETHVLENDIAMIN-RUECKSTAND, HMD-VORLAUF
- Analytical purity: 93.88%
- Impurities (identity and concentrations) > 0.1%: Aminoethylcyclopentylamine 3.57%, Hexamethylenimine 1.35%, Hexylmethylendiamine 0.74%, Pentylmethylendiamine 0.33%, other impurities 0.13%
- pH: 12-13 (10% aqueous solution)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae, Biberach, Germany
- Mean weight at study initiation: males 198 g, females 182 g (+- 20%)
- Fasting period before study: 16 h
- Housing: 5 per cage in stainless steel wire mesh cages, Typ DK-III
- Diet (e.g. ad libitum): Kliba-Labordiet, Klingenthalmuehle AG, Kaiseraugst, Switzerland; ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS in fully air-conditioned rooms
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 6.81-21.5% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 10 mL
Doses:
681, 1000, 1470 and 2150 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: several times on the day of administration and at least once each workday; check for moribund and dead animals twice each workday and once on holidays; weighing on day 0, 3, 5, 7 and 13
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 170 mg/kg bw
Based on:
test mat.
95% CL:
1 000 - 1 360
Remarks on result:
other: LD50 of male rats: ca. 1327 mg/kg bw; LD50 of female rats: ca. 1000 mg/kg bw
Mortality:
681 mg/kg bw: 0 males and 0 females died
1000 mg/kg bw: 0 males and 2 females died
1470 mg/kg bw: 4 males and all females died
2150 mg/kg bw: all animals died
All animals that died were dead within 1 day after administration
Clinical signs:
other: 681 mg/kg bw: no clinical signs observed 1000 mg/kg bw: dyspnea, apathy, staggering (only females), piloerection (only females) and poor general state were reversible within one day after administration 1470 mg/kg bw: dyspnea, apathy, abnormal position (o
Gross pathology:
Animals-that died (male and female) :
General congestive hyperemia
Stomach/small intestines: filled with bloody contents
Glandular stomach: diffusely red (gastritis by corrosion)

Sacrificed animals (male and female):
no abnormalities detected.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test condition the test substance has an LD50 value of 1170 mg/kg bw.
Executive summary:

In a study similar to OECD guideline 401, test substance was administered via oral gavage to 5 male and 5 female Wistar rats per dose group (681, 1000, 1470 and 2150 mg/kg bw). The LD 50 value was calculated to be 1170 mg/kg bw. Clinical signs included dyspnea, apathy and poor general state.