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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1978
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:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no weighing was performed; exposed area of the low dosed animals only 4% of the total body surface
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
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): 1,2-Diaminocyclohexan
- Physical state: liquid
- Analytical purity: 98%
- pH: 14

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Wiga, Sulzfeld, D
- Mean weight at study initiation: males 193 g, females 164 g

ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and lateral parts of the trunk
- % coverage: 1600-3200 mg/kg bw: ca. 42 cm² -->10% of the total body surface; 1000 mg/kg bw: ca. 12 cm = ca. 4% of the total body surface (considering a mean body weight of 185 g and the formula: body surface area = 10 * (weight (g) *exp 0.67))
- Type of wrap if used: aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and water/Lutrol
Duration of exposure:
24 h
Doses:
1000, 1600, 2000, 2500 and 3200 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 after day 0 was not reported
- Necropsy of survivors performed: yes
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 870 mg/kg bw
Based on:
test mat.
95% CL:
1 700 - 2 050
Remarks on result:
other: LD50 for males: not calculated; LD50 for females: 1786 mg/kg bw
Mortality:
1000 mg/kg bw: 0 males and 0 females died
1600 mg/kg bw: 0 males and 1 females died within 24 hours
2000 mg/kg bw: 3 males and 4 females died; thereof, 5 animals died within 48 hours
2500 mg/kg bw: all animals died within 48 hours
3200 mg/kg bw: all animals died within 24 hours
Clinical signs:
other: other: screaming directly after application, high-stepping gait on the day of administration (>= 1600 mg/kg bw), strong apathy (not reversible at the 1600 mg/kg bw treatment, reversible within 6 days at the 1000 mg/kg bw treatment)
Gross pathology:
Animals that died: (right) heart dilatation, congestion hyperemia, pale liver and kidneys
Surviving animals: nothing abnormal observed
Other findings:
24 hours after application, animals showed formation of necrosis; within the observation period, open and moisted necrosis were observed (local concentration ranged from ca. 38 to 77 mg test substance/cm² skin for the 1600-3200 mg/kg bw treatment and ca. 83 mg/ cm² skin for the 1000 mg/kg bw treatment due to the smaller exposure area of this treatment)

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the applied test condition the test substance has an LD50 value of 1870 mg/kg bw.
Executive summary:

In a study similar to OECD guideline 402, test substance was administered under occlusive conditions for 24 h to the skin of 5 male and 5 female Sprague-Dawley rats per dose group (1000, 1600, 2000, 2500 and 3200 mg/kg bw) . The LD 50 value was calculated to be 1870 mg/kg bw.