Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Study conducted to recognised testing guidelines with GLP certification.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Organization for Economic Cooperation and Development (1981) OECD Short-Term and LongvTerm Toxicology Groups. Final Report: Acute Dermal Irritation & Corrosion
Cater, R.O. & Griffith, J.F., (1965). Experimental Basis for the Realistic Assessment of Safety of Topical Agent. Toxicol. Appl. Pharm. 1., 60-75.
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animal origin:
"Padre Antonio" breeding center, Mariano Comense - CO— Italy

Weight:
2.000 - 3.000 kg

Housing:
Environmental conditions
Housing overpressure environment compared to the external atmosphere, maintained at following conditions:
Temperature: 0 °C ± 3 °C
Humidity: 55% ± 15% Relative humidity
Air parts: At least eight per hour

Cages:
Model 1472 stainless steel cages of the company "Tecuiplast" Gazzada (Varese). Cycle of 10 seconds automatic washing every 60 minutes.

Food supply:
Complete pelletized diet

Acgua:
"Ad libitum". Municipal water supply system filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.

Quarantine:
One week

Preparation of animals:
Animal health conditions are check 24 hours before the test starts. The back of the animals is shaved by doing be careful not to damage the skin. Only animals with intact skin are used.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1.0 g/animal
Duration of treatment / exposure:
24 hours
Observation period:
After 24 hours the gauze is removed and the skin reactions are immediately evaluated. The evaluation is then repeated 72 hours after application. The skin reactions are re-evaluated after five and seven days to determine the reversibility or irreversibility of the lesions observed.
Number of animals:
6
Details on study design:
Administration:

The back and sides of the animals are shaved. Two areas about 10 cm apart. are designated for affixing the material in question.

The fiance area is abraded by practicing with the tip of a needle three light epidermal incisions along parallel lines, of about 3 cm. and distant 0.5 cm.

The engravings are of exclusive interest the stratum corneum and are not so deep as to cause bleeding. The material under examination is absorbed on two surgical gauze tablets (2.5x2.5 cm) consisting of 12 layers.

The two tablets are fixed to the sides of the animal using a hypoallergenic adhesive tape (Blenderm BM). The entire trunk of the animal is further protected by an elastic bandage (Acrylastic Beyersdorf AG Hamburg).
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
Intact and scarified
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
Intact and scarified
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance does not meet the criteria for classification under CLP.
Executive summary:

In this guideline study, the test substance (EC 402-990-3) was found not to meet the criteria for classification as a skin irritant/corrosive under CLP.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Organisation for Economic Co-operation and Development (1979).
OECD Short-term and Long-term Toxicology Groups, Final Report:
Acute Eye Irritation/Corrosivity, 31 December, p. 40
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
Source: "Padre Antonio" Mariano breeding center
Weight: 2.000-3.000 Kg.
Quarantine: A week
Diet: Pellets
Water: water
Ad libitum. Municipal water supply system filtered with Seitz filter, chemically and bacteriologically analyzed twice a year.

Preliminary selection: Animal health conditions are check 24 hours before the test. All animals with irritation or other eye defects are discarded

ENVIRONMENTAL CONDITIONS
Pressure: Atmospheric pressure
Humidity: 55 ± 15% relative humidity
Air changes (per hr): At least 8
Cages: Model 1472 stainless steel cages of the"Tecniplast" company ~ Gazzada - VA - Italy - with automatic washing cycle 10 seconds every 60 minutes
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1g/animal applied once
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes of rabbits were examined at intervals of 1-24-48-72 hours from application. In the cases where corneal damage or irritation occurs persistent ocular examination, additional observations were conducted for the purpose of determining the reversibility or irreversibility of any injuries observed.
Number of animals or in vitro replicates:
One group of 6 animals
Details on study design:
The material under examination is instilled in the outer corner of the right eye of each rabbit slightly pushing the lower eyelid apart. After instillation the eyelids are closed and pressed lightly so as to avoid any loss of material. It is the untreated left eye that served as a control.

The eyes of the rabbits were examined in the following order: a) conjunctiva, b) iris, c) cornea. The lesions of the iris and cornea were exami ned either for direct observation and for lighting with ultraviolet lamp (365 nm) later fluorescein instillation.

The severity of injuries is expressed in points, according to the numerical scale illustrated in the annex table 1 (Draize, J. It., Woodward, G. and Calvary, H. 0. (1944). Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the skin and Mucous Membranes, J. Pharmacol. Exp. Ther. 82 377-390).

Any other injury not relevant to the cornea, iris or conjunctiva data was also recorded and reported.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
All animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The substance EC 402-990-3 is not classified as an eye irritant under CLP.
Executive summary:

In this guideline study, the substance (EC 402-990-3) is not sufficiently irritant to be classified under CLP criteria.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The substance does not meet the criteria for classification in accordance with the classification, labelling and packaging regulation (EC 1272/2008).