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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 / corrosion
Adequacy of study:
other information
Study period:
1992
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): ADAMQUAT BZ 80
- Physical state: liquid
- Analytical purity: 78.5% (in water)
- Impurities (identity and concentrations): Acrylic acid (0.54%), dimethylaminoethyacrylate (0.55%); EMHQ (0.0378%)
- Composition of test material, percentage of components: 100%
- Purity test date: 06/12/1991
- Lot/batch No.: op 611/613/615/616
- Expiration date of the lot/batch: 12/1992
- Stability under test conditions: stable
- Storage condition of test material: in the dark at room temperature

Test animals

Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel, France)
- Age at study initiation: no data
- Weight at study initiation: 2.5 ± 0.1 kg
- Housing: individually housed in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20% relative humidity
- Air changes (per hr): The air was non-recycled and filtered by absolute filters.
- Photoperiod (hrs dark / hrs light): 12 hours of light/12 hours of dark

IN-LIFE DATES: From: 16/01/1992 To: 25/01/1992

Test system

Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 hours
Observation period:
9 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: right flank
- % coverage:
- Type of wrap if used: semi-occlusive

REMOVAL OF TEST SUBSTANCE: no, since no residual was found

SCORING SYSTEM: Draize's score
Examination time points: 1h, 24 h, 48 h and 72 hours

Results and discussion

In vivo

Resultsopen allclose all
Time point:
other: 1 hour
Score:
2
Max. score:
4
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Time point:
other: 1 hour
Score:
0.7
Max. score:
4
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Very slight and well-defined erythema was observed after application of the test substance in all animals. The mean scores were 0.0, 1.0 and 2.0 for each animal. A slight oedema was noted in one animal after one hour. Cutaneous reactions had reversed after 24 hours in one animal and from day 5 in the second animal. Very slight erythema and/or dryness of the skin persisted until day 9 in the last animal.

Any other information on results incl. tables

 Rabbit Number day 1 day 2 day 3 day 4 day 5 day 6 day 7 day 8
  1 hour 24 hour 48 hour 72 hour
 Erythema
01 2 0 0 0 - - - -
02 2 2 2 2 1 1/S 1/S 1/S
03 2 1 1 1 0 - -  -
Oedema
01 0 0 0 0 - - - -
02 0 0 0 0 0 0 0 0
03 2 0 0 0 0 - - -

S = dryness of the skin

- = Animals without reaction at the 72 hour scoring period were no longer observed

Applicant's summary and conclusion

Conclusions:
ADMAQUAT BZ 80 is not irritating to the skin of the rat.