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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 April 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to GLP and internationally accepted test guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,3-bis(aminomethyl)cyclohexane
- Physical state: liquid
- Stability under test conditions: not specified
- Storage condition of test material: room temperature in darkness

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.91 kg
- Housing: individually housed in a suspended metal cage.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period:5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 21°C
- Humidity (%): 65%
- Air changes (per hr): fifteen per hour
- Photoperiod (hrs dark / hrs light):12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml


TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 ml
Duration of treatment / exposure:
3 minutes
Observation period:
1 hour
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 3 sites, each 2.5 cm x 2.5 cm
- Type of wrap if used: BLENDERM (2.5 cmx 4.0cm ) tape to hold cotton gauze over application site and TUBIGRIP elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): site washed with distilled water
- Time after start of exposure: 3 minutes, all patches were removed at that time.

SCORING SYSTEM:
Erythema and Eschar Formation: No erythema, 0; very slight erythema (barely perceptible, 1; Well-defined erythema, 2; moderate to severe erythema, 3; severe erythema (beet redness) to slight eschar formation (injuries in depth), 4.

Oedema Formation
No oedema, 0; very slight oedema (barely perceptible), 1; slight oedema (edges of area well-defined by definite raising, 2; moderate oedema (raised approximately 1 millimetre),3; severe oedema (raised more than 1 millimetre and extending beyond the area of exposure), 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The animal was killed for humane reasons following the 1-hour observation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
other: not applicable
Remarks on result:
other: erythema scores considered to be of low relevance due to severe necrosis early in the test.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
0
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: The animal was killed for humane reasons following the 1-hour observation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Reversibility:
other: not applicable
Remarks on result:
other: edema scores considered to be of low relevance due to severe necrosis early in the test.
Irritant / corrosive response data:
Green coloured necrosis was noted over the whole of the test site at the 1-hour observation. A loss of elasticity and drying of the skin was also noted. The animal was killed for humane reasons following the 1-hour observation in accordance with current UK Home Office guidelines and Safepharm company policy.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
The test material, 1,3-BAC, was classified as CORROSIVE to rabbit skin according to EU labeling regulations.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single 3-minute semi-occluded application of the test material to the intact skin of one rabbit produced corrosive effects.

4-hour and 1-hour semi-occluded applications of the test material to the intact skin were therefore not investigated.