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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize
GLP compliance:
no
Remarks:
prior to GLP guidelines

Test material

Constituent 1
Reference substance name:
GM102E
IUPAC Name:
GM102E
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.