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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:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Amines, tallow alkyl
EC Number:
263-125-1
EC Name:
Amines, tallow alkyl
Cas Number:
61790-33-8
IUPAC Name:
61790-33-8
Constituent 2
Reference substance name:
Tallow Alkylamines
IUPAC Name:
Tallow Alkylamines
Details on test material:
- Name of test material (as cited in study report): Genamin TA 100 D

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Germany
- Age at study initiation: ca. 3 - 5 month
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: individually, stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hour interval

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
500mg/patch
Duration of treatment / exposure:
3 min (3 animals)
4 h (1 animal)
Observation period:
0.5 - 1, 24, 48, and 72 h
7, 14, and 21 days
Number of animals:
4 (3 for 3 min exposure, 1 for 4 h exposure)
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: approx. 6.25 cm²

REMOVAL OF TEST SUBSTANCE
- Washing: water
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: semi-occlusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after exposure period of 4 hours or 3 minutes


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 min exposure
Time point:
other: 0.5 - 1 h
Score:
1.67
Max. score:
2
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 min exposure
Time point:
other: 0.5 - 1 h
Score:
2
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
3 min exposure
Time point:
other: mean 24, 48, 72 h
Score:
2
Max. score:
2
Remarks on result:
other: redness around sclerosis
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
3 min exposure
Time point:
other: mean 24, 48, 72 h
Score:
2.33
Max. score:
3
Remarks on result:
other: swelling around sclerosis at 72 h observation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
3 min exposure
Time point:
other: mean 24, 48, 72 h
Score:
2.67
Max. score:
3
Remarks on result:
other: redness around sclerosis
Irritation parameter:
edema score
Basis:
animal #2
Score:
3.33
Max. score:
4
Remarks on result:
other: swelling around sclerosis at 72 h observation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
3 min exposure
Time point:
other: mean 24, 48, 72 h
Score:
2
Max. score:
2
Remarks on result:
other: redness around sclerosis
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
3 min exposure
Time point:
other: mean 24, 48 h
Score:
3
Max. score:
3
Remarks on result:
other: edema not evaluable after 72 h due to sclerosis
Irritation parameter:
other: overall erythema score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
2.22
Max. score:
3
Remarks on result:
other: redness around sclerosis
Irritation parameter:
other: overall edema score
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
2.88
Max. score:
4
Remarks on result:
other: swelling around sclerosis at 72 h observation; in one animal, edema not evaluable after 72 h due to sclerosis
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 0.5 - 1 h
Score:
3
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: 0.5 - 1 h
Score:
3
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 h
Score:
3
Max. score:
3
Remarks on result:
other: around sclerosis
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
4 h exposure
Time point:
other: mean 24, 48, 72 h
Score:
3
Max. score:
3
Irritant / corrosive response data:
3 min exposure: The test item caused very slight to moderate erythema and slight to moderate oedema. Both, erythema and oedema was partly evaluable only around sclerosis or not evaluable due to sclerosis. 24 h until 14 days after patch removal, the skin was sclerotic, arched upward, discoloured (brown), fissured, scabbed, incrusted, dry, scaled, parchmenty, and pink. Additionally, ablation of the skin was observed. After 14 days, all animals showed scars.

4 h exposure: From 0.5 - 72 h after patch removal, moderate erythema and oedema were observed. Up to day 7, the skin was sclerotic, arched upward, incrusted, scabbed, discoloured (white or brown-white, respectively) and showed exudation. On day 7, a very slight erythema around the sclerosis was observed. Oedma was not evaluable due to sclerosis. The skin was destructed in full thickness. The animal was humanely killed.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the study results, Genamin TA 100 D was corrosive to skin.
Executive summary:
In a GLP conform study, Genamin TA 100 D was tested for skin irritation / corrosion according to OECD test guideline 404. for this 0.5 g of undiluted Genamin TA 100 D was applied semi-occlusively for 3 minutes or 4 hours to the shaved skin of three or one New Zealand White rabbits, respectively. The skin then was examined 30 minutes, 1 hour, 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7 and 14 days. Results for the 3 minute exposure period (3 animals): From 30 minutes to 14 days after patch removal, the treated skin sites showed mild to moderate erythema and mild to strong oedema. Between 24 hours and 14 days, the treated skin areas were sclerotic, vaulted, brownish discoloured, cracked, dry-brittle, scaly, translucent and pink-coloured. Additionally scaling was observed. After 14 days, all animals showed scars. Due to the severity of effects, scoring of erythema and oedema was restricted. Results for the 4 hour exposure period (1 animal): From 30 minutes to 7 days after application, the skin was temporarily sclerotic, vaulted, encrusted, scabby, white and brown-white discoloured. Additionally, exudations were observed. Full thickness destruction of the epidermis had occurred after 7 days and the animal was killed for human reasons on day 7. Due to the severity of effects, scoring of erythema and oedema was restricted. Based on the results of this study, Genamin TA 100 D was corrosive to skin.