Registration Dossier

Administrative data

Description of key information

No irritation observed in two acute toxicity studies with dust inhalation and in a 28-day study with daily dust inhalation in rats.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Purity and physicochemical properties of test substance not given, sex, strain, and age of test animals not given.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
scoring according to Draize
Deviations:
yes
Remarks:
no one hour scoring, no use of anaesthetics, separate groups of 3 animals with eyes washed at 2 or 4 seconds after application
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No details reported
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
applied to eyes and not washed - maximum 24 hours until first examination
applied to eyes and washed - 2 or 4 seconds
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 groups of 3 animals each
Details on study design:
Application to right eyes, left eyes served as controls, 0.1 ml applied undiluted, in one group each the eyes were washed after 2 and 4 seconds, one group remained unwashed, 3 rabbits per group, recording of irritant effects according to Draize after 24, 48, and 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effect observed
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
not irritant
Other effects:
none
Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the provisions of regulation 1272/2008, Annex I, 3.3, Dechlorane Plus is not classified as irritating to rabbit eyes.
Executive summary:

Groups of 3 rabbits each were applied with 0.1 ml of Dechlorane Plus undeluted into the right eye, while the left eye served as control. In two groups, the treated eyes were washed after 2 or 4 seconds. The reactions were recorded at 24, 48, and 72 hours after application according to Draize. No irritant effect at all was observed in any animal at any time point. Dechlorane Plus was completely non irritant.

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

Respiratory irritation

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

Additional information

No irritation of the respiratory tract was seen in two acute dust inhalation studies at concentrations of 2.25 and 300 mg/l in rats and in a 28 -day dust inhalation study in rats at concentrations up to 1,524 mg/l in air.

Justification for selection of skin irritation / corrosion endpoint:

No skin irritation was seen in an acute toxicity study with dermal application of up to 8,000 mg/kg bw on intact and abraded skin, only minimal local erythema without dose dependence was seen in a 28-day study with dermal application of 500 or 2,000 mg/kg bw firstly occurring after 18 days of daily application. Without any dose dependence, this may have been caused by the application technique.

Justification for selection of eye irritation endpoint:

In vivo study using 3 groups of 3 rabbits each, meeting the recommendations of OECD 405. No effect at all observed in any rabbit at any time point.

Justification for classification or non-classification

No irritation observed in two acute toxicity studies with dust inhalation and in a 28-day study with daily dust inhalation in rats.