Registration Dossier

Diss Factsheets

Administrative data

Description of key information

- Acute Dermal Irritation/Corrosion (Draize method): only slight irritation effects observed on rabbits exposed during 8 hours.
- Acute Eye Irritation/Corrosion (Draize method): severe eye damages were observed in rabbits exposed to the test item during 30 seconds.
- There was no evidence of respiratory irritation reported in the acute inhalation toxicity in rats.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Prior to GLP, but standard procedure well described.
Qualifier:
according to guideline
Guideline:
other: Draize
GLP compliance:
no
Remarks:
prior to GLP guidelines
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ditta Attilio Sala, Milano
- Age at study initiation: no data
- Weight at study initiation: 2000 g
- Housing: individual macrolon cages
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: > or = 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3
- Humidity (%): 60% +/- 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 11 hours light/day

IN-LIFE DATES: From: 31-May-1983 To: 03-June-1983
Type of coverage:
occlusive
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 mg
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
8 h
Observation period:
3 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- % coverage:
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: Draize scale

Irritation parameter:
erythema score
Remarks:
for the intact skin sites
Basis:
mean
Remarks:
for the 6 animals and 3 time points
Time point:
other: 24-48-72 hours
Score:
0.4
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Max. duration: 72 hrs; Max. value at end of observation period: 0
Irritation parameter:
edema score
Remarks:
for the intact skin sites
Basis:
mean
Remarks:
Mean for the 6 animals and 3 time points
Time point:
other: 24-48-72h
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 3days; Max. value at end of observation period: 0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: Draize scoring
Time point:
other: 24 hours (highest value)
Score:
0.7
Max. score:
8
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: practically non-irritating
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 3 days
Interpretation of results:
not classified
Remarks:
Migrated information CLP criteria REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
The test material produced only minimal transient irritation.
Executive summary:

The skin irritant potential of the test item GM102E was investigated in a test performed on New Zealand White rabbits according to the Draize method. 

200 mg of test item was applied during 8 hours on the dorsal area of 6 animals with an occlusive coverage. The effects were observed during 3 days after application.

Very slight erythema reactions were observed on several rabbits but these reactions were reversible within the end of the observation period (3 days). Thus the substance is considered as a very slight skin irritant.

Based on these results and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), GM102E should not be classified for skin irritation.

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:
other: Prior to GLP, but standard procedure well described.
Qualifier:
according to guideline
Guideline:
other: Draize
GLP compliance:
no
Remarks:
prior to GLP guidelines
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ditta Attilio Sala, Milano, It.
- Age at study initiation: no data
- Weight at study initiation: 2000 g
- Housing: individual macrolon cages
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: > or = 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +/- 3
- Humidity (%): 60% +/- 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 11 hours light

IN-LIFE DATES: From: 31 May 1983 To: 1 June 1983
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
Intended: 1 min, 1, 2, 4 24, 48, 72 hours, day 4 and day 7.
Number of animals or in vitro replicates:
9 intially intended. Due to severe irritation observed in the first 2 animals, the study was terminated.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): intended in 3 out of the 9 animals. Only one animal was eventually tested with rinse out, due to severe effects observed..
- Time after start of exposure: 30 seconds following application

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: #1 and #2
Time point:
other: From 2 hours after instillation
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks:
study terminated after 24 hours due to severe effects
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 3
Irritation parameter:
chemosis score
Basis:
animal: #1 and #2
Time point:
other: From 24 hours after instillation
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
study terminated after 24 hours due to severe effects
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 4
Irritation parameter:
cornea opacity score
Basis:
animal: #1 and #2
Time point:
other: From 24 hours after instillation
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
study terminated after 24 hours due to severe effects
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 4
Irritation parameter:
iris score
Basis:
animal: #1 and #2
Time point:
other: From 2 hours after instillation
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
study terminated after 24 hours due to severe effects
Remarks on result:
other: Max. duration: 24 h; Max. value at end of observation period: 2. [missing part of the results, most likely score 2 at 2 hours and beyond]
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 1 day
The study was terminated after 24 hours following observations of severe effects in 2 rabbits. No further animals were treated.
Other effects:
The ocular lesions reached the maximum for each paramater within 24 h after the administration of the substance. The lesions caused severe damage to the eyes and the animals were humanly sacrificed due to poor conditions.
Rinsing the eyes within 30 seconds after application (1 animal) did not produce significant changes in the severity of the effects.
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Severe ocular effects were observed within 2 to 24 hours after treatment. The study was terminated.
Executive summary:

The eye irritant potential of the test item GM102E was investigated in a test performed on New Zealand White rabbits according to the Draize method. 

100 mg of test item was applied during 30 secondes before washing. The effects were intended to be observed during 7 days after application.

The study was terminated after 24 hours following observations of severe effects in 2 rabbits. No further animals were treated.

The ocular lesions reached the maximum for each parameter within 24 h after the administration of the substance. The lesions caused severe damage to the eyes and the animals were humanly sacrificed due to poor conditions.

Rinsing the eyes within 30 seconds after application (1 animal) did not produce significant changes in the severity of the effects.

Based on these results and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), GM102E should be classified for serious eye damage (Eye dam. Category 1, H318).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

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

Additional information

Skin corrosion/irritation:

The skin irritant potential of the test item GM102E was investigated in a test performed on New Zealand White rabbits according to the Draize method. 

200 mg of test item was applied during 8 hours on the dorsal area of 6 animals with an occlusive coverage. The effects were observed during 3 days after application.

Very slight erythema reactions were observed on several rabbits but these reactions were reversible within the end of the observation period (3 days). Thus the substance is considered as a very slight skin irritant.

Based on these results and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), GM102E should not be classified for skin irritation.

Eye corrosion/irritation:

The eye irritant potential of the test item GM102E was investigated in a test performed on New Zealand White rabbits according to the Draize method. 

100 mg of test item was applied during 30 secondes before washing. The effects were intended to be observed during 7 days after application.

The study was terminated after 24 hours following observations of severe effects in 2 rabbits. No further animals were treated.

The ocular lesions reached the maximum for each parameter within 24 h after the administration of the substance. The lesions caused severe damage to the eyes and the animals were humanly sacrificed due to poor conditions.

Rinsing the eyes within 30 seconds after application (1 animal) did not produce significant changes in the severity of the effects.

Based on these results and according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), GM102E should be classified for serious eye damage (Eye dam. Category 1, H318).

Justification for selection of skin irritation / corrosion endpoint:
Only one reliable study available.

Justification for selection of eye irritation endpoint:
Only one reliable study available.

Effects on eye irritation: corrosive

Justification for classification or non-classification

The test material appears to have very slight skin irritation effects in in vivo studies with rabbits. Thus, GM102E is not classified for skin irritation according to Regulation (EC) 1272/2008 (CLP).

GM102E caused severe damage to eyes in a Draize test on rabbits and thus the test item is classified as Eye Dam. 1 (H318) according to Regulation (EC) 1272/2008 (CLP).