Registration Dossier

Administrative data

Description of key information

The substance should be regarded as a moderate skin irritant and a severe eye irritant. 

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: albino rabbits, strain HC:NZW
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral untreated skin area of test animals served as control
Amount / concentration applied:
Amount: 0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours, 7 and 14 days after application
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: Fixomull - stretch Klebeflies, semiocclusive

REMOVAL OF TEST SUBSTANCE
- Washing: treated skin area carefully washed with water without altering the existing response of the integrity of the epidermis
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean of 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean of 24, 48, 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: slight oedema (mean score: 0.3)
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean of 24, 48, 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: slight oedema (mean score: 0.3)
Irritant / corrosive response data:
erythematous and exsudative reactions; in 2 animals not proved to be fully reversible within 14 days
mean irritation index calculated by averaging the total scores of all 6 rabbits: erythema and eschar formation (2.02), oedema formation (0.1)
Other effects:
There were no systemic intolerance reactions recorded.
Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information
Conclusions:
moderately irrtating to skin



Classification: not irritating
Executive summary:

In a GLP compliant skin irritation study performed according to OECD 404 the test substance was shown to be an irritant to the rabbits skin. No relevant systemic intolerance reactions were observed.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: albino rabbits, strain HC:NZW
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd, Wyton Huntingdon, England
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 2 weeks
Vehicle:
unchanged (no vehicle)
Controls:
other: one untreated eye of test animals served as control
Amount / concentration applied:
Amount: 0.1 ml

Duration of treatment / exposure:
after placing the test substance into the conjunctional sac of the rabbits eye the lids were held together for about one second. 24 hours after treatment the treated eye was rinsed with saline.
Observation period (in vivo):
1, 24, 48, 72 hours and 7, 14, and 21 days post application. 
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eye was rinsed at 24 hours after instillation

SCORING SYSTEM: Draize
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: area of cornea opacity: more than 3/4 up to complete surface
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
other: discharge
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 hours
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Other effects:
There were no systemic intolerance reactions recorded.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information
Conclusions:
severely irritating to the eye


Classification: not irritating
Executive summary:

In an eye irritation test on rabbits according to OECD 405, the test substance led to marked inflammatory reactions of the corna, iris and conjunctivae in one animal. Discharge was observed. Corneal and conjunctival signs and discharge did not prove to be reversible within 21 days. No systemic intolerance reactions were recorded. Due to animal welfare reasons no further animals were treated. The test substance was shown to induce severely irritating effects to the eye of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Desmorapid 01 can be chemically described as ‘butanoic acid, 3-oxo-, methylester, reaction products with N,N-dimethyl-1,3-propanediamine and propylene glycol ether with trimethylol propane (3:1) (CAS-No. 646505-36-4)’ or (different description of the same substance) ‘poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate’ (CAS-No. 857285-61-1). The closely related CAS-No. 179733-18-7 describes the same substance and differs only in the manufacturing process where ethanol is distilled off while for the other two CAS-Nos. methanol is distilled off (see IUCLID section 1.1). Thus, toxicological data for all three CAS-Nos. are considered relevant for the substance to be registered and are taken into account for human health assessment.

Skin irritation:

In a GLP compliant skin irritation study performed according to OECD 404 the test substance (CAS-No. 179733 -18 -7) was shown to be an irritant to the rabbit's skin. No relevant systemic intolerance reactions were observed.

Eye irritation:

In an eye irritation test on rabbits according to OECD 405, the test substance (CAS-No. 179733 -18 -7) led to discharge and marked inflammatory reactions of the corna, iris and conjunctivae in one animal which did not prove to be reversible within 21 days. No systemic intolerance reactions were recorded. Due to animal welfare reasons no further animals were treated. The test substance was shown to induce severely irritating effects to the eye of rabbits.

Respiratory tract irritation:

No data are available for respiratory tract irritation. Inhalation of the gaseous substance is unlikely since the vapour pressure of the substance is very low. In case of aerosol contact an irritating potential to the respiratory tract can be assumed, since the substance is classified as severe eye irritant.


Justification for selection of skin irritation / corrosion endpoint:
only one study available

Justification for selection of eye irritation endpoint:
only one study available

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on the study results the substance should be classified as skin irritant Category 2 and severe eye irritant Category 1 according to Regulation 1272/2008 EC.