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Diss Factsheets

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:
From 3 October 2001 to 16 October 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-morpholinopropylamine
EC Number:
204-590-2
EC Name:
3-morpholinopropylamine
Cas Number:
123-00-2
Molecular formula:
C7H16N2O
IUPAC Name:
3-morpholin-4-ylpropan-1-amine
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: no data
- Expiration date of the lot/batch: no data
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (10-30°C)
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: not applicable, test item was tested neat

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was dosed neat as received from the sponsor.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: 3 male and 3 female New Zealand White rabbits - HM (NZW) fBR; Hare Marland
- Age at study initiation: 18-19 weeks
- Weight at study initiation: 3.3-3.4 kilograms
- Housing: individually, in compliance with USDA guidelines.
- Diet (e.g. ad libitum): all animals had access to Teklad Certified Rabbit Diet or equivalent
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days during which each animal was observed at least once daily for any abnormalities or for the development of infectious disease.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours artifical light/12 hours dark

IN-LIFE DATES: From: 2001-10-03 To: 2001-10-16

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site on the clipped dorsal trunk of each animal
Duration of treatment / exposure:
3 minutes, 60 minutes and 4 hours
Observation period:
14 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: the trunk of each animal was wrapped with an elastic bandage and non-irritating tape to prevent animal access to the test sites and possible ingestion/inhalation of the test article.
- Within 24 hours before the test, the fur was removed from the dorsal area of the trunk of each rabbit, being careful to avoid abrading the skin. The test article was administered once to each of three sites on the clipped dorsal trunk of each animal. For all sites the test article was applied directly to the skin and covered with a gauze patch. The patch was held in contact wih the skin with a semi-occlusive dressing (rubber sheeting).
- The test item was also administered to one intact site of the upper left dorsal trunk of the animal (3-minute exposure).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed, without altering the existing response or the integrity of the epidermis. After the 3-min exposure time, the site was unwrapped and washed with mineral oil and gauze.
- Time after start of exposure: 3 minutes, 60 minutes or 4 hours

OBSERVATION TIME POINTS
- erythema, edema and necrosis: immediately after patch removal and then daily through day 14. The 3-min exposure site was also scored at 55-60 minutes after patch removal. The 4-hour exposure site was scored at 24, 48 and 72 hours (+/- 1 hour).

SCORING SYSTEM:
- according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
necrosis
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
necrosis
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
necrosis and blanching
Irritation parameter:
erythema score
Remarks:
4 hour exposure
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicale
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
4 hour exposure
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritation parameter:
erythema score
Remarks:
3 min exposure
Basis:
mean
Remarks:
animal # 2, 3, 4, 5 & 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
3 min exposure
Basis:
mean
Remarks:
all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Remarks:
animal # 2 & 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
mean
Remarks:
animal # 3 & 5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
necrosis and blanching
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Remarks:
1 h exposure
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
mean
Remarks:
animal # 3 & 5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal # 2, 4 & 6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
1 h exposure
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 5 days
Irritant / corrosive response data:
- 3- minute exposure: well-defined erythema and no edema, no other dermal signs noted
- 60-minute exposure: severe erythema and severe edema. Necrosis, fissuring, sloughing, flaking and blanching were also noted.
- 4-hour exposure: severe erythema and severe edema. Necrosis, fissuring, sloughing, flaking and blanching were also noted.
Other effects:
The test article was classified as non-corrosive using Corrositex (r) System technique and the study procceeded with testing in the animal model.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
The test article was found to be a sever irritant. The test article was also found to be corrosive according to DOT Classification (Packing Group II). The primary irritation index was calculated as follows:
Exposure OECD PII OSHA PII
4 hour 5.1 5.4
Based on the criteria of the CLP regulation (EC) No. 1272/2008, the test item should be classified as category 1 (corrosive), subcategory 1B (Corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days).