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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:
from 15-JUN-2002 to 01-JUL-2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The test was performed according to OECD guideline and GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Deviations from the maximum level of temperature occurred (with a maximum of 1 °C). It was considered not to have affected the study integrity.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Remarks:
Tests based on dissolved material in the concentrate
Details on test material:
- Name of test material (as cited in study report): Aldolase (IUB 4.1.2.4)
- Substance type: enzyme
- Physical state: liquid
- Stability under test conditions: data not available
- Storage condition of test material: In freezer in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: 7-9 weeks
- Weight at study initiation: 1557g to 1662g
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 56x44x37.5cm)
- Diet: Standard laboratory rabbit diet (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England) approx. 100 g. per day
- Water: Free access to tap-water
- Acclimation period: at least 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 3°C
- Humidity: 30-70%
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12 hours artificial fluorescent light and 12 hours dark per day


IN-LIFE DATES: data not available

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent areas of the untreated skin of each animal served as controls
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 (in a first time one single rabbit, and 2 other 13 days later)
Details on study design:
TEST SITE
- Area of exposure: the test substance was applied to the skin of one flank, using a metalline patcht of 2x3 cm
- % coverage: data not available
- Type of wrap if used: the patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (with water)
- Time after start of exposure: 4 hours


SCORING SYSTEM: erythema and edema were scored in accordance with OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No skin irritation was caused by 4 hours exposure to ALDOLASE (I.U.B. 4.1.2.4).
There was no evidence of a corrosive effect on the skin.
Other effects:
No staining of the treated skin by the test substance was observed.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1 : individual skin irritation scores

Animal #

339 (sentinel)

370

371

Time after exposure

erythema

oedema

comments

erythema

oedema

comments

erythema

oedema

comments

1 hour

0

0

-

0

0

-

0

0

-

24 hours

0

0

-

0

0

-

0

0

-

48 hours

0

0

-

0

0

-

0

0

-

72 hours

0

0

-

0

0

-

0

0

-

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results and according to the EC criteria, ALDOLASE (I.U.B. 4.1.2.4) does not have to be classified and has no obligatory labelling requirement for skin irritation
Executive summary:

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4, "Acute Toxicity - Skin irritation" and OECD No.404, "Acute Dermal Irritation/Corrosion".

Three rabbits were exposed to 0.5 ml of ALDOLASE (I.U.B. 4.1.2.4), applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irritation was caused by 4 hours exposure to ALDOLASE (I.U.B. 4.1.2.4).

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), ALDOLASE (I.U.B. 4.1.2.4) does not have to be classified and has no obligatory labelling requirement for skin irritation.