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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.4 - 2.7 kg
- Housing: fully air-conditioned rooms, seperate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat - Kaninchen, Altromin GmbH, Lage/Lippe, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum

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

IN-LIFE DATES: from 1984-11-20 to: 1984-12-11
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (moistened with 0.4 mL physiological saline)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4 mL isotonic saline
Duration of treatment / exposure:
4 hrs; 60 minutes; 3 minutes (3 animals each)
Then test substance was removed from the skin with warm tap water
Observation period:
30 - 60 min. after removal of the patches
24, 48 and 72 hrs after removal of the patches
7, 14, 21 days after removal of the patches
Number of animals:
9
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The moistened substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plater (specially produced by Beiersdorf AG, Hamburg. The plaster was fixed to the prepared skin area (ca. 25 cm2) and then covered with a semi-occlusive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm tap water
- Time after start of exposure:
animals #1-3: 3 min.
animals #4-6: 1 hr
animals #7-9: 4hrs


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 (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Irritation parameter:
erythema score
Basis:
other: mean all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
edema score
Basis:
other: mean all animals
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h / 48h / 72h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: application time 3 min
Irritation parameter:
erythema score
Basis:
other: mean all animals
Time point:
other: 24h / 48h / 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h / 48h / 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h / 48h / 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h / 48h / 72h
Score:
2
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
edema score
Basis:
other: mean all animals
Time point:
other: 24h / 48h / 72h
Score:
0.9
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h / 48h / 72h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h / 48h / 72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: application time 1 hr
Irritation parameter:
erythema score
Basis:
other: mean all animals
Time point:
other: 24h / 48h / 72h
Score:
1.2
Max. score:
2
Remarks on result:
other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
1
Remarks on result:
other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h / 48h / 72h
Score:
1
Max. score:
2
Remarks on result:
other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24h / 48h / 72h
Score:
1.7
Max. score:
2
Remarks on result:
other: application time 4 hrs, assessment of application site not possible, surrounding skin was assessed
Irritant / corrosive response data:
Following 3 minute exposure no skin reactions were observed. Following 60 minute exposure skin reactions indicative of an irritative response were observed which were fully reversible 14 days p.a.. Following 4 hours exposure scare formation was observed in all 3 animals 21 days p.a.
Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Testing of the substance for primary dermal irritation in the rabbit showed that, based on the criteria laid down in the Directive 83/467/EEC, the substance has to be labelled as corrosive (C) with the designation R34 - causes burns.
Executive summary:

C12 -18 -(even numbered, C18 unsaturated)-alkylamines acetates was tested for skin irritation / corrosion according to OECD test guideline 404 in rabbits. Each animal was treated with 500 mg Cocoalkylamine acetate moistened with 0.4 mL isotonic saline and covered by semi-occlusive bandage. The exposure period was 3 min, 1 hour and 4 hours. After the exposure period all remnants were carefully removed from the skin with warm tap water. Readings were performed 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches. Because effects were still present after 72 hours, additional readings were performed after 7 days 14 and 21 days.

Following a three minute exposure peride, the test material is considered to be not irritating to skin.

After a contact time of 1 hour C12 -18 -(even numbered)-alkylamines acetates was irritating. There were clear localized erythema and slight edema. The surface of the skin was dry, brittle, with fine and coarse scales, parchment-like, chapped and light brown. After 21 days the skin had healed without scarring.

After a contact time of 4 hours, the treated skin became hardened, arched and green-brown to brown. From 14 days after removal of the patches, for the treated skin desquamation of coarse / fine scales causing scar and eschar formation was observed. The application sites were sharply defined against the surrounding skin . Due to the strong hardening of the skin erythema and edema formation could only be assessed at the surrounding skin of the application site, but not at the application site itself.

Based on these results, technically pure Cocoalkylamine acetate must be considered as corrosive to skin following a 4 hour exposure period.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion