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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is quite old and not performed to current guidelines.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA: Toxic substances Guidelines, HG- organ/tissue- dermal irritation. 1987
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine
EC Number:
500-311-6
EC Name:
N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine
Cas Number:
120498-03-5
IUPAC Name:
1,3-Propanediamine,N-N’’-1,2-ethanediylbis- reaction product with 1,3,5-triazine-2,4-diamine,N,N’-dibutyl-6-chloro-N,N’-bis(2,2,6,6-tetramethyl-4-piperidinyl), polymer with N-butyl-4,6-dichloro-N-(2,2,6,6-tetramethyl-4-piperidinyl)-1,3,5-triazin-2-amine
Details on test material:
Name of test material (as cited in study report): TABANOL 4

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
3 males and 3 females with a body weight of ca 2.5 - 3 kg approx. 2 - 3 months old.
The animals were acclimatised for approx. 4 weeks prior to treatment.
They were housed in individual cages in air conditioned rooms maintained at 22 ± 2 °C with air changes approx 12/hour.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g/animal
Duration of treatment / exposure:
4 hours
Observation period:
Total 72 hours
Number of animals:
6
Details on study design:
As the test system was a solid it was applied directly onto the gauze patch.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: up to 72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Up to 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
Only one animal showed very slight erythema 24 hours after treatment.
Other effects:
No other effects

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 by dermal route to rabbits under the experimental conditions adopted, is to be considered non irritant for the skin.