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Diss Factsheets

Administrative data

Description of key information

The submission substance was found to be non-irritating to the skin and eyes during two separate studies on the New Zealand White rabbit and a skin irritation study conducted with human volunteers.

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
Study period:
The study was performed between 27 September and 30 september 1995.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 31/01/1994 Date of signature: 16/03/1994
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Source: David Percival Ltd., Moston, Sandbach, Chesire, UK- Age at study initiation: 12 to 16 weeks old- Weight at study initiation: 2.41 to 2.67 kg- Housing: The animals were housed individually in suspended metal cages.- Diet: Free acess allowed throughout the study to STANRAB SQC Rabbit Diet.- Water: Free acess allowed throughout the study to mains drinking water.- Acclimation period: minimum of 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 21°C- Humidity (%): 56 to 65%- Air changes (per hr): approximately 15 changes per hour- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darknessIN-LIFE DATES: From: Day 0 To: End of study
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped free of fur
Vehicle:
other: moistened with distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.5 g was moistened with 0.5 ml of distilled water- Concentration (if solution): not applicableVEHICLEnot applicable
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE- Area of exposure: 2.5 cm x 2.5 cm- % coverage: not stated- Type of wrap if used: surgical adhesive tape (BLENDERM: approximate sixe 2.5 cm x 4 cm)REMOVAL OF TEST SUBSTANCE- Washing (if done): removed by gentle swabbing with cotton wool soaked in distilled water.- Time after start of exposure: 4 hoursSCORING SYSTEM:The score for erythema and oedema at the 24 and 72 hour readings were totalled for the 3 test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material.The EU classification system was used
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: calculated at 24, 48 and 72 hours.
Score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
108 Female
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
114 Female
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
erythema score
Remarks:
91 Female
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Remarks:
108 Female
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Remarks:
114 Female
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Remarks:
91 Female
Basis:
mean
Time point:
other: mean score for 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible

The individual score for erythema/eschar and oedema are given in Table 1. Mean values required for EU labelling regulations are given in Table 2. (Please see Attachment 1).

Very slight erythema was noted at 2 treated skin sites one hour after patch removal.

All treated skin sites appeared normal at the 24 hour observation period.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, PX-200, produced a primary irritation index of 0.0 and was classified as a non irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute dermal irritation/corrosion" (adopted 17 July 1992) and Method B4 of Commission directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

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
Study period:
The study was performed between 28 June 1999 and 2 July 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1997 (SI 1997/654)).
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK- Age at study initiation: twelve to sixteen weeks- Weight at study initiation: 2.64 to 2.74 kg- Housing:suspended metal cages- Diet: ad libitum - Water: ad libitum- Acclimation period: at least five daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 23°C- Humidity (%): 30 to 70%- Air changes (per hr): approximately fifteen changes per hour- Photoperiod (hrs dark / hrs light): controlled by a time switch to give twelve hours continuous light and twelve hours darknessIN-LIFE DATES: From: Day 1 To: 72 hours
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit):0.1 ml which was found to weigh approximately 96 mg- Concentration (if solution): not applicableVEHICLE- Amount(s) applied (volume or weight with unit): not applicable- Concentration (if solution): not applicable- Lot/batch no. (if required): not applicable- Purity: not stated in report
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): not conducted- Time after start of exposure: not applicableSCORING SYSTEM: Kay and Calandra classification systemTOOL USED TO ASSESS SCORE: light source from a standard opthalmoscope
Irritation parameter:
cornea opacity score
Basis:
animal: 145 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
cornea opacity score
Basis:
animal: 96 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
cornea opacity score
Basis:
other: 97 Male
Time point:
other: Mean of 24, 48 and 72hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
animal: 145 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
other: 96 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
animal: 97 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 145 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 observed at 1 hour
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 96 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 at 1 hr.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 97 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 at 1 hr
Irritation parameter:
chemosis score
Basis:
animal: 145 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Score of 2 at 1 hr, residual test material located in eye
Irritation parameter:
chemosis score
Basis:
animal: 96 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks on result:
other: Score of 1 at 1 hr
Irritation parameter:
chemosis score
Basis:
animal: 97 Male
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no effects observed
Remarks on result:
other: Score of 1 at 1 hr
Irritant / corrosive response data:
A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. dulling of the normal lustre of the cornea was also noted in one treated eye. All treated eyes appeared normal at the 48-hour observation.
Other effects:
None noted.

A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Dulling of the normal lustre of the cornea was also noted in one treated eye. All treated eyes appeared normal at the 28 hour observation.

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbols and risk phrases are required.
Executive summary:

The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 405 and Method B5 of Commission Directive 92/69/EEC (which constitutes Annex V of Council directive 67/548/EEC).

The test material did not meet the criteria for classification as irritant according to EU labelling regulations. No symbols and risk phrases are required.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A human patch volunteer study was conducted for the purposes of worker safety assessment under the supervison of a medical practitioner and according to a Japanese dermatological standard. In addition, a study was performed for the purposes of EU NONS notification to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used was OECD Guideline No. 404. A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal at the 24 -hour observation.

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. following OECD Guideline No. 405. A single application of the test material to the non-irrigated eye of three rabbits produced moderate conjunctival irritation. Dulling of the normal lustre if the cornea was also noted in one treated eye. All treated eyes appeared normal at the 48 -hour observation.

Reliability.

The above studies have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Justification for classification or non-classification

The test material did not meet the criteria for classification as irritant or corrosive according the EU labelling regulations during the dermal irritation study.

The test material did not meet the criteria for classification as an irritant (to the eye) according to EU labelling regulations. No symbol and risk phrases are required.