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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:
December 29, 1998 - January 1, 1999
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: Polyamide
CAS: No. 68990-47-6
Batch No.: CEM 2158/9
Characteristics: very viscous dark mass
Storage conditions: in a dark and cool place

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Conelli snc
- Age at study initiation: 2-3 mounth old
- Weight at study initiation: 2-3 kg
- Housing: the same room of treatment
- Diet : ad libitum)
- Water : from the municipal water main

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/-2 °C
- Humidity (%): 55% +/- 10
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 h circadian cycle

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 g/site
epidermal, single dose
Duration of treatment / exposure:
Exposure times: 3 minutes, 1 hour and 4 hours.
Observation period:
Immediately and 72 hours after the 3 minute and the 1 hour exposure period in the first rabbit and at 1, 24, 48 and 72 hours after the 4 hours exposure period (all rabbits).
Number of animals:
3 males

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hour
Score:
0.34
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hour
Score:
0.34
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48/72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

No changes were seen were the test article was applied for 3 minutes or 1 hour.

At the sites exposed for 4 hours erythema grade 1 was detected in all rabbits at the reading carried out 24 h from the end of exposure period.Erythema grade 1 was concomitantly observed in a single rabbit.

At the 48 hours reading very slight erythema still persistent in a single animal.

No dermal effects observed at the last reading (72 hours).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article when administered to rabbits by dermal route, is to be considered NON IRRITANT for the skin.