Registration Dossier

Administrative data

Description of key information

skin irritation: in vivo study after failed in vitro study due to the test item was not compatible with the test system

eye irritation: read-across to existing in vivo study

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study after failed in vitro study due to the test item was not compatible with the test system
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11/11/2016-03/03/2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
OECD Guidelines for Testing of Chemicals, No. 404, “Acute Dermal Irritation/Corrosion” adopted 28 July 2015
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Commission Regulation (EC) No 440/2008, L 142, Annex Part B, Method B.4, 30 May 2008
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
EPA Health Effects Test Guidelines, OPPTS 870.2500 “Acute dermal irritation”, EPA 712-C-98-196,
(August 1998)
Qualifier:
according to
Guideline:
other: Directive 2010/63/EU
Version / remarks:

Procedures and facilities comply with the requirements of Directive 2010/63/EU and the national legislation defined in the animal protection law concerning the protection of animals used for experimental and other scientific procedures
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
The test item was used as delivered by the sponsor.
In order to ensure good skin contact, it was moistened with aqua ad injectionem (AlleMan Pharma, lot no. 601101, expiry date: 12/2018)
The vehicle was chosen due to its non-irritating characteristics.
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to the German Act on Animal Welfare the animals were bred for experimental purposes.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Remarks:
Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
Vehicle:
other: aqua ad injectionem
Amount / concentration applied:
A dose of 0.5 g of the test item was applied to each test site.
Duration of treatment / exposure:
The test item was not expected to produce corrosion, but might be irritating. Therefore, a single patch was applied to one animal for 4 hours.
Observation period:
The animals were observed for 72 hours after the patch removal.
Number of animals:
2
Details on study design:
The test item was applied at a single dose to a small area (approximately 6 cm2) of skin on one side of the dorsal area and covered with a gauze patch, which was held in place with a non-irritating tape. The untreated other side served as control. The test item was applied to the patch first and then applied to the skin. To ensure good skin contact, the test item was moistened with the vehicle. The patch was fixed with a semi-occlusive dressing. The limits of the application site were marked with an ink marker.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
>= 0 - <= 1
Max. score:
1
Remarks on result:
other: pink/purple staining of the skin by the test substance
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
<= 0
Max. score:
0
Remarks on result:
other: pink/purple staining of the skin by the test substance
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, the single dermal application of the test item MKP1003 to two rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects.
Neither mortalities nor significant clinical signs of toxicity were observed.
According to Annex I of Regulation (EC) 1272/2008, the test item MKP1003 does not have to be classified and has no obligatory labelling requirement for skin irritation.
According to GHS (Globally Harmonized Classification System), the test item MKP1003 has no obligatory labelling requirement for skin irritation.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation, other
Remarks:
read-across to existing in vivo study
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Justification for type of information:
see attachment
Reason / purpose:
read-across source
Reason / purpose:
reference to other study
Reason / purpose:
read-across: supporting information
Remarks on result:
positive indication of irritation
Remarks:
worst-case assumption to classify as eye irritant cat. 2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Reversibility:
fully reversible
Remarks on result:
other: minimal irritation observed
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification