Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1993 to April 1993
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Standardised method following EC Dir 84/449, although some details are missing in the report.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
Annex V B.3, Dir. 84/449/EEC
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Reference substance name:
Test material form:
solid: particulate/powder
migrated information: powder
Details on test material:
white powder

Test animals

Details on test animals or test system and environmental conditions:
- Strain: Sprague Dawley Crl: CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: 7-9 weeks
- Weight at study initiation: Males: 225-250g ; Females: 200 - 225 g
- Fasting period before study:
- Housing: individual grill cages
- Diet (e.g. ad libitum): ad libitum, except fasting period prior to dosing
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days

- Temperature (°C): 22°C+/2 2
- Humidity (%): 55% +/- 10
- Air changes (per hr): 20/hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12 hour cycle (light 7 am-7 pm)

IN-LIFE DATES: From: 25 March 1993 To: 9 April 1993

Administration / exposure

Type of coverage:
not specified
No details provided in the report.
Details on dermal exposure:
- Area of exposure: dorsal surface
- % coverage: 10%
- Type of wrap if used: porous gauge dressing

- Washing (if done): No washing. After exposure period, residual substance was wiped off.
- Time after start of exposure: 24 hours

- For solids, paste formed: No details were provided in the report, but the method followed (EC Dir. Annex V, B.3, 94/449) indicates that the powder should be moistened with water.
Duration of exposure:
24 h
2000 mg/kg
No. of animals per sex per dose:
5 Males and 5 females/dose
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs observed at 30 min, 2, 4, 6 hours post dosing, then twice daily
weight: twice before dosing (at randomisation and on day 1 before treatment), then on day 8 and 15

- Necropsy of survivors performed: yes (gross pathology)
- Other examinations performed:
clinical signs: yes
body weight: yes
organ weights: no
histopathology: no
No (limit test)

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Clinical signs:
other: Signs of toxicity related to dose levels: Clinical signs prior to death of the single female that died on day 2: piloerection and hunched posture. Surviving animals: no clinical signs or altered behaviour observed.
Gross pathology:
Congestion and increased size of the spleen in the single female rats which died during the study.
No changes at the end of the observation period in the other animals.
Other findings:
Signs of toxicity (local):
Local irritation was observed on all animals at the application site up to days 3-11 of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information EU CLP criteria Criteria used for interpretation of results: EU
The dermal LD50 value of GM102E in Sprague-Dawley rats was established to be > 2000 mg/kg. One female rat died and local irritation was observed on all animals at the application site up to days 3-11 of the study.
Executive summary:

The acute dermal toxicity of the test item GM102E was investigated in a limit test performed on Sprague Dawley rats. 

The study was performed according to EU method B.3 and in compliance with GLP.

The test item was administered once on 5 males and 5 females using patch applied on the dorsal surface. The test item was tested at the concentration of 2000 mg/kg. No washing was performed and residual substance was wiped off after 24-hour exposure period.

The animals were then observed during 14 days. Clinical signs were observed at 30 min, 2, 4, 6 hours post dosing, then twice daily while weight was measured twice before dosing (at randomisation and on day 1 before treatment), then on day 8 and 15.

One female rat died during the study (day 2). Piloerection and hunched posture were observed before death and congestion and increased size of the spleen were the only findings at autopsy. No general clinical signs were seen in the surviving animals, but they showed erythema, edema, and crusts at the application site starting from days 2-3 and lasting up to days 3-11 of the study. The body weight gain appeared normal. No changes were found at the gross pathology examination performed at the end of the observation period in any rat.

Mortality was confined to only one animal and only local irritation was observed at the application site on the other rats. Thus the LD50 was considered to be > 2000 mg/kg b.w.

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 dermal toxicity.