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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
From 05 OCT 1988 to 23 NOV 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Principles of method if other than guideline:
Skin sensitisation test in guinea pigs. Primary irritation phase (1 drop open epikutan). Two days thereafter followed by induction phase (4 intradermal injections with 0.1 ml of 1% (v/v) emulsion, 1 injection per week). Challenge treatment (open epicutan) of animals was done two weeks after last induction injection. Rechallenge was performed in the same way as challenge procedure but one week thereafter.
GLP compliance:
yes
Remarks:
according to US EPA regulations
Type of study:
intracutaneous test

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-cyclohexanediamine (DCH)
- Substance type: colourless liquid
- Physical state: fluid
- Analytical purity: 89 %
- Impurities (identity, but no quantities mentioned):
hexamethylenediamine
hexamethyleneimine
2-methylpentamethylenediamine
2-(aminomethyl)cyclopentylamine
- Stability under test conditions: the test material was assumed to be stable under the conditions of administration

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: epicutaneous applications: water; intradermal injections: physiological saline
Concentration / amount:
primary irritation: 1 drop of 1 or 10 % emulsion of test substance in distilled water (vehicle control group treated with water)
sensitisation: 4 sacral intradermal injections (1 each week) of 0.1 mL of a 1.0 % (v/v) emulsion of test substance (vehicle control group treated with physiological saline)
challenge: 1 drop of 1 or 10 % emulsion of test substance in distilled water (vehicle control group treated with water, negative control animals also treated)
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: epicutaneous applications: water; intradermal injections: physiological saline
Concentration / amount:
primary irritation: 1 drop of 1 or 10 % emulsion of test substance in distilled water (vehicle control group treated with water)
sensitisation: 4 sacral intradermal injections (1 each week) of 0.1 mL of a 1.0 % (v/v) emulsion of test substance (vehicle control group treated with physiological saline)
challenge: 1 drop of 1 or 10 % emulsion of test substance in distilled water (vehicle control group treated with water, negative control animals also treated)
No. of animals per dose:
10 animals (5 males, 5 females) in the test dose group,
5 vehicle control animals (3 males , 2 females),
10 positive control animals (5 males, 5 females)
2x5 animals (in each group 2 males, 3 females) in negative control group (one group received at challenge test material the other group positive control substance).
Positive control substance(s):
yes
Remarks:
p-phenylenediamine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
10%
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
4/9 animals showed slight erythema, 1/9 mild erythema and 3/9 moderate erythema, 1 animal died during induction phase.
Remarks on result:
other: clincal observation: 4/9 animals showed slight erythema, 1/9 mild erythema and 3/9 moderate erythema, 1 animal died during induction phase.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
8
Total no. in group:
9
Clinical observations:
4/9 animals showed slight erythema, 1/9 mild erythema and 3/9 moderate erythema, 1 animal died during induction phase.
Remarks on result:
other: Clinical observations: 4/9 animals showed slight erythema, 1/9 mild erythema and 3/9 moderate erythema, 1 animal died during induction phase.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
1 animal died during induction phase
Remarks on result:
other: Clinical observations: 1 animal died during induction phase.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
1 animal died during induction phase
Remarks on result:
other: Clinical observations: 1 animal died during induction phase.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
3
Total no. in group:
5
Clinical observations:
slight erythema observed
Remarks on result:
other: Clinical observation: slight erythema observed
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 %
No. with + reactions:
3
Total no. in group:
5
Clinical observations:
slight erythema observed
Remarks on result:
other: Clinical observation: slight erythema observed
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
other: vehicle control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
other: vehicle control
Dose level:
0
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
30% p-phenylenediamine
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
2/10 animals showed slight erythema, 6/10 mild erythema and 1/10 moderate erythema
Remarks on result:
other: Clinical observations: 2/10 animals showed slight erythema, 6/10 mild erythema and 1/10 moderate erythema
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
30% p-phenylenediamine
No. with + reactions:
9
Total no. in group:
10
Clinical observations:
4/10 animals showed slight erythema, 4/10 mild erythema and 1/10 moderate erythema, 2 animals showed oedema
Remarks on result:
other: Clinical observations: 4/10 animals showed slight erythema, 4/10 mild erythema and 1/10 moderate erythema, 2 animals showed oedema
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
3 % p-phenylenediamine
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
5/10 animals showed slight erythema, 1/10 mild erythema
Remarks on result:
other: Clinical observations: 5/10 animals showed slight erythema, 1/10 mild erythema
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
3 % p-phenylenediamine
No. with + reactions:
4
Total no. in group:
10
Clinical observations:
3/10 animals showed slight erythema, 1/10 mild erythema
Remarks on result:
other: Clinical observations: 3/10 animals showed slight erythema, 1/10 mild erythema

Any other information on results incl. tables

Rechallenge (one week after the challenge) under the same conditions as the challenge resulted in comparable results. Body weight gain was normal in all animals.

erythema scores:

0: no erythema

1: slight erythema

2: mild erythema

3: moderate erythema

4: severe erythema

Applicant's summary and conclusion

Interpretation of results:
other: ambiguous, according to authors: mild dermal sensitiser
Conclusions:
Under the applied test conditions, results of this skin sensitisation assay with guiunea pigs are ambiguous, as corrosiveness of the substance complicated interpretation of results. A rechallenge exposure therfore was needed. According to the study authors the test substance reveals weak skin sensitising effects taken the results from the rechallenge exposure.
Executive summary:

In an intracutaneous guinea pig test 5 male and 5 female guinea pigs were treated with two concentrations of test substance each (10 % or 1 % of test material; i.e. Primary irritation phase (1 drop open epikutan). Two days thereafter followed by induction phase (4 intradermal injections with 0.1 ml of 1% (v/v) emulsion, 1 injection per week). Additional animals were used as negative and positive control animals. After challenge (open epicutaneous, was done two weeks after last induction injection) with the test substance animals in the 10 % group showed very slight to moderate erythema in the 24 and 48 h reading (8/9 and 8/9 animals). In the corresponding negative control group 3/5 animals showed slight erythema in the 24 and 48 h reading, revealing the irritant potential of the test substance at this concentration level. In the 1 % test group no effects were observed. Due to this observed results rechallenge was performed in the same way as challenge procedure but one week thereafter. 48 hours after rechallenge with 10% of test material 6/9 animals showed slight or mild erythema, whereas none of the negative control animals showed skin response. In the 1 % test group and negative control group no effects were observed.

Under the applied test conditions, results of this skin sensitisation assay with guinea pigs are ambiguous, as corrosiveness of the substance complicated interpretation of results. A rechallenge exposure therefore was needed. According to the study authors the test substance reveals weak skin sensitising effects taken the results from the rechallenge exposure.