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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10-13 January 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Species and strain: New Zealand White rabbits
Source: S&K-LAP Kft.
2173 Kartal, Császár út 135, HUNGARY
Justification of strain: The New Zealand White albino rabbit is one of the standard strains used for acute irritation toxicity studies.
Animal health: Only animals in acceptable health condition were used for the test.
Number of animals: 3
Age of animals at treatment: ~13 weeks old
Sex: Male
Body weight range at the
beginning of the life phase: 3288-3491 g
at the end of the life phase: 3366-3515 g
Date of receipt: 21 December 2011
Acclimation time: 20 days
Animal identification: The animals were identified by engraved ear tags. The cages were marked with individual identity cards with information about study code, sex, cage number, dose group and individual animal number.

Husbandry
Number of animal room: 609
Lighting periods: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature range during the study: 20 ± 3 °C
Relative humidity during the study: 30-70%
Housing/Enrichment: Rabbits were individually housed in AAALAC approved metal wire rabbit cages (65x65 cm with height of 45 cm). Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
Ventilation: 15-20 air exchanges/hour

The environmental parameters were recorded twice daily during the acclimatisation and experimental phases.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after the patch removal
Number of animals:
3
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0

Animal No./

Body weight (g)

1 h 24 h 48 h 72 h

Sex

at the beginning of the study

at the end of the study

00396/ M 3288 3366 0 0 0

0

00386/M 3325 3390 0 0 0

0

00381/M 3491 3515 0 0 0

0

TOTAL - - 0 0

0 0

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritant to skin.
Executive summary:

The primary skin irritation has been assessed by application to the clipped and shaved skin of three male rabbits in accordance with the OECD 404 test guideline in compliance with GLP. Following 4 hour semi-occluded exposure, skin reactions were recorded 1, 24, 48 and 72 h after exposure and resulted in no skin reactions. The substance is therefore not irritant to skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20-23 June 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
A single dose of 0.1 g of the solid test item was administered to each animal
Duration of treatment / exposure:
The eyes of the test animals were washed out at 1 hour after application of test item.
Observation period (in vivo):
Clinical Observations
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill-health during the study were recorded. At the end of the observation period, each animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol® 40% anaesthesia (see details in 3.2.). Death was verified by checking pupil and corneal reflex and the absence of respiration.
Number of animals or in vitro replicates:
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition and any with ocular lesions were rejected.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0
Max. score:
0
Irritation parameter:
other: Redness
Basis:
mean
Time point:
other: 24, 48 & 72 hrs
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hrs
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is therefore not irritant to eyes
Executive summary:

The acute eye irritation has been assessed by application to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP. Following exposure of 1 hour, the eyes were washed, eye reactions were recorded 1, 24, 48 and 72 h after exposure. All effects to the eyes were completelt reversible within 48 hours. The substance is therefore not irritant to eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
in vivo skin irritation test. K1 quality. Data generated in compliance with GLP

Justification for selection of eye irritation endpoint:
in vivo eye irritation test. K1 quality. Data generated in compliance with GLP

Justification for classification or non-classification

The primary skin irritation has been assessed by application to the clipped and shaved skin of three male rabbits in accordance with the OECD 404 test guideline in compliance with GLP. Following 4 hour semi-occluded exposure, skin reactions were recorded 1, 24, 48 and 72 h after exposure and resulted in no skin reactions. The substance is therefore not irritant to skin.

The acute eye irritation has been assessed by application to the eyes of three male rabbits in accordance with the OECD 405 test guideline in compliance with GLP. Following exposure of 1 hour, the eyes were washed, eye reactions were recorded 1, 24, 48 and 72 h after exposure. All effects to the eyes were completelt reversible within 48 hours. The substance is therefore not irritant to eyes.