Registration Dossier

Administrative data

Description of key information

Ditetradecyl peroxydicarbonate was neither irritant to skin nor irritant to eye based on the results obtained in an in vivo skin irritation study (OECD 404, 1981) and an in vivo eye irritation study (OECD 405, 1987).

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:
1992-10-05 to 1992-10-22
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:
1981
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Directive 84/449/EEC
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: approximately three and a half months old
- Weight at study initiation: 2.38 - 2.85 kg
- Housing: in a lagomorph room within a limited- access buiding
- Diet: free access to a commercially available standard pelleted rabbit diet
- Water: free access to tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 22 °C
- Humidity: 45 - 56 %
- Air changes: 15 complete air changes per hour without re-circulation
- Photoperiod: a lighting cycle of 12 hours of artificial light per day

IN-LIFE DATES: From: 1992-10-05 To: 1992 10-22
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:
single treatment
Observation period:
72 hours
Number of animals:
3 rabbits
Details on study design:
TEST SITE
- Area of exposure: 3 x 2 cm
- Type of wrap if used: unmedicated gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing: washed with warm water and dried with paper towels to remove excess test material adhering to the skin
- Time after start of exposure: 4 hour

SCORING SYSTEM:
Criteria for assessment of skin irritation responses:
1) Erythema and eschar formation:
- No erythema: 0
- Very slight erythema (barely perceptible): 1
- Well-defined erythema: 2
- Moderate to severe erythema: 3
- Severe (beet redness) to slight eschar formation (injury in depth) : 4

2) Oedema formation:
- No oedema: 0
- Very slight oedema (barely perceptible): 1
- Slight oedema (edges of area weel-defined by definite raising): 2
- Moderate oedema (raised approximately 1 mm): 3
- Severe oedema (raised more than 1 mm and extending beyond the area of exposure): 4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal response was observed at the test site of any animal at any time during the 72 hour observation period.
The control sites did not show any response to the control procedure.
Interpretation of results:
GHS criteria not met
Conclusions:
Ditetradecyl peroxydicarbonate was classified as non-irritant to the skin.
Executive summary:

The potential of ditetradecyl peroxydicarbonate to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings.

No dermal response was observed at the test site of any animal at any time during the 72 hour observation period.

Ditetradecyl peroxydicarbonate was classified as non-irritant to the skin.

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 vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-10-05 to 1992-11-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
Directive 84/449/EEC
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: approximately three and a half to four and a half months old
- Weight at study initiation: 2.72 - 3.58 kg
- Housing: in a lagomorph room within a limited-access building
- Diet: free access to food hoppers containing standard pelleted rabbit diet
- Water: free access to tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 - 20 °C
- Humidity: 50 - 58 %
- Air changes: approximately 15 complete air changes per hour without re-circulation
- Photoperiod: a lighting cycle of 12 hours artifical light per day

IN-LIFE DATES: From: 1992-10-05 To:1992-11-06
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
once
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : none

SCORING SYSTEM:
Criteria for assessment to pain response:
1) Reaction of animal to instillation of test material:
- No response: 0 (No initial pain)
- A few blinks only; normal within one or two minutes: 1 ( Practically no initial pain)
- Rabbit blinks and tries to open eye but the reflexes close it: 2 (slight inittal pain)
- Rabbit holds eye shut and puts pressure on lids; may rub eye with paw: 3 (Moderate initial pain)
- Rabbit holds eye shut vigorously; may squeal: 4 (Severe initial pain)
- Rabbit holds eye shut vigorously; may squeal, claw at eye and try to escape: 5 (Very severe initial pain)

2) Criteria for assessment of ocular lesions:
2a) Cornea:
- No opacity: 0
- Scattered or diffuse aeas of opacity, (other than slight dulling of normal lustre) details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
- Complete corneal opacity, iris not discernible: 4

2b) Iris:
- Normal: 0
- Markedly deepened folds, congestion, swelling, moderate circumcorneal injection: 1
- No reaction to light, haemorrhage, gross destruction: 2

2c) Conjunctivae:
Redness:
- Vessels normal: 0
- Some vessels definitely injected: 1
- Diffuse, crimson-red, individual vessels not easily discernible: 2
- Diffuse beefy-red: 3

Chemosis:
- No swelling: 0
- Any swelling above normal: 1
- Obvious swelling with partial eversion lids: 2
- Swelling with lids about half-closed: 3
- Swelling with lids more than half-closed: 4

3) Additional criteria for assessment of ocular lesions:
3a) Cornea:
Area of cornea affected by lesion:
- No lesion: 0
- One- quarter or less, but not zero: 1
- Greater than one-quarter, less than one half: 2
- Greater than one-half, less than three-quarters: 3
- Greater than three-quarters, up tp whole area: 4

3b) Conjunctivae:
Discharge:
- No discharge: 0
- Any amount differnt from normal: 1
- Discharge with moistening of the lids and hairs just adjacent to the lids: 2
- Discharge with moistening of the lids and hairs and affecting a considerable area around the eye: 3
- Extensive mucoid discharge: 4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
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:
4
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:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
A diffuse crimson-red conjunctival appearance or injection of the conjunctival blood vessels was observed in all rabbits during the first 48 hours following instillation of the test item. Very slight or slight chemosis and discharge were observed during the first 24 hours after treatement. Iritis was observed in one rabbit at the 24-hour examination.
The test eye of two rabbits was overtly normal at the 48 hour examination and the third rabbit at the 72 hour examination.
Instillation of the test material caused slight or practically no pain response.
Interpretation of results:
GHS criteria not met
Conclusions:
Ditetradecyl peroxydicarbonate was classified as non-irritant to the eye.
Executive summary:

The potential of ditetradecyl peroxydicarbonate to cause damage to the conjunctiva, iris or cornea was assessed in three New Zealand White rabbits, each subjected to a single ocular instillation of 0.1 g of the test material. Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment.A diffuse crimson-red conjunctival appearance or injection of the conjunctival blood vessels (mean score 0.5), very slight or slight chemosis (mean score 0.1) and discharge were observed in all rabbits during the first 48 hours following instillation. Iritis was observed in one rabbit at the 24 hour examination (individual score 0.3). The test eyes of all rabbits were overtly normal at the 72 hour examination. Instillation of the test item caused a very slight initial pain response. Ditetradecyl peroxydicarbonate was classified as non-irritant to the eye.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

The potential of ditetradecyl peroxydicarbonate to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal response was observed at the test site of any animal at any time during the 72 hour observation period. Ditetradecyl peroxydicarbonate was classified as non-irritant to the skin.

 

Eye

The potential of ditetradecyl peroxydicarbonate to cause damage to the conjunctiva, iris or cornea was assessed in three New Zealand White rabbits, each subjected to a single ocular instillation of 0.1 g of the test material. Ocular reactions were assessed 1, 24, 48 and 72 hours after treatment.

A diffuse crimson-red conjunctival appearance or injection of the conjunctival blood vessels (mean score 0.5), very slight or slight chemosis (mean score 0.1) and discharge were observed in all rabbits during the first 48 hours following instillation. Iritis was observed in one rabbit at the 24 hour examination (individual score 0.3). The test eyes of all rabbits were overtly normal at the 72 hour examination. Instillation of the test item caused a very slight initial pain response. Ditetradecyl peroxydicarbonate was classified as non-irritant to the eye.

Justification for classification or non-classification

Based on the negative in vivo skin and eye irritation studies, classification is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.