Registration Dossier

Administrative data

Description of key information

Skin irritation / corrosion in vivo (OECD 404): not irritating

Eye irritation / serious eye damage in vivo (OECD 405): not irritating

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:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Cheshire, UK.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2000 - 3500 g
- Housing: Metal Cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Shorn Skin
- Type of wrap if used: Elasticated corset and surgical adhesive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
of all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test substance produced no skin reaction in any animal at any reading time point.
Other effects:
No effects observed.

Table 1: Individual skin reactions

 Skin reaction

 Observation tim

 Animal #1

 Animal #2

 Animal #3

 Erythema / eschar formation

 1 h

 0

 0

 0

 24 h

 0

 0

 0

 48 h

 0

 0

 0

   72 h  0  0  0
 Edema formation  1 h  0  0  0
   24 h  0  0  0
   48 h  0  0  0
   72 h  0  0  0
         
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Propylidentrimethanol, propoxylated is not an irritant to the rabbit skin.
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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Cheshire, UK.
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2000 - 3500 g
- Housing: Suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was used as control
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not rinsed

SCORING SYSTEM: Draize Scoring System

TOOL USED TO ASSESS SCORE: Standard opthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Dulling of the normal lustre of the cornea was noted in one treated eye 1 h after treatment. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 h after treatment. Iridial inflammation was noted in all treated eyes 1 and 24 h after treatment. Moderate conjunctival irritation was noted in all treated eyes 1, 24 and 48 h after treatment with minimal conjunctival irritation noted 72 h after treatment. Moderate to minimal swelling (chemosis) was found at the 1, 24 and 48 h reading in all animals.

AVERAGE SCORE (24,48,72 hours) per animal 1 / 2 / 3
- Cornea: 0.0 / 0.3 / 0.3
- Iris: 0.3 / 0.3 / 0.3
- Conjunctivae (Redness): 1.7 / 1.7 / 1.7
- Conjunctivae (Chemosis): 0.7 / 1.0 / 1.0

All treated eyes appeared normal after 7 days.

Additional data supporting the information is attached below under 'Attached background material'.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Propylidentrimethanol, propoxylated resulted in only slight irritation of the skin of rabbit, which was fully reversible within 7 days.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion

The skin irritation potential of propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) was investigated in an in vivo study performed according to OECD guideline 404 under GLP conditions (rel 1-key, rabbit, OECD 404, Safepharm, 2002c, 1691/006). 0.5 mL of the unchanged test substance was applied to the clipped skin of three New Zealand White rabbits under semi-occlusive conditions. 4 h after application the patch was removed from each animal and residual test material was removed by gentle swabbing with cotton wool soaked in distilled water. Approx. 1 h following the removal of the patch as well as 24, 48 and 72 h later, the test sites were examined for evidence of primary irritation and scored according to the Draize scheme. The test substance produce no skin reaction in any animal at any observation time point. Therefore, propylidentrimethanol, propoxylated is considered not irritating to the skin.

Eye irritation / serious eye damage

Propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) was examined for its eye irritation potential in an in vivo study performed according to OECD guideline 405 under GLP conditions (rel 1-key, rabbit, OECD 405, Safepharm, 2002d, 1691/007). Initially, a single rabbit was treated and a volume of 0.1 mL of the test substance was instilled into the conjunctival sac of the right eye. The left eye remained untreated and was used as control. Immediately after administration, an assessment of the initial pain reaction was made. After consideration of the ocular responses of the first treated animal, two additional animals were treated. Assessment of occular lesions was made approx. 1,  24. 48 and 72 h as well as 7 days following treatment according to the Draize scheme. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 h after treatment resulting in corneal opacity scores of 1, fully reversible within 48 h. Iridial inflammation was observed in all treated eyes 24 h after treatment with individual scores of 1 but was fully reversible within 48 h. Moderate conjunctival irritation (redness) was noted in all treated eyes (individual scores of 2, 2 and 1 after 24, 48 and 72 h, respectively, in all animals) and fully reversed within 7 days. In addition, minimal conjunctival chemosis was observed in all animals at the 24 and 48 h reading points (individual scores 2/1 for two rabbits and 2/2 for the third animals at 24 and 48 h, respectively). The conjunctival irritation was not apparent any more 72 h after treatment. In conclusion, propylidentrimethanol, propoxylated is considered not irritating to eyes.

Justification for classification or non-classification

The available data on skin and eye irritation with propylidentrimethanol, propoxylated (CAS No. 25723-16-4, EC No. 500-041-9) do not meet the criteria for classification according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.