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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
From 29 January 2002 to 27 February 2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study without detailed documentations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
dated july 17th, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
dated december 29th, 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
ADHBFA-Me
IUPAC Name:
ADHBFA-Me
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste - 40260 Linxe)
- Age at study initiation: no data
- Weight at study initiation: 2.35-2.42 kg
- Housing: individual boxes installed in conventional air conditioned animal husbanding
- Diet: no data
- Water: no data
- Acclimation period: 7-8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 38-47
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: undamaged skin
Vehicle:
unchanged (no vehicle)
Controls:
other: left flank of each test animal treated with distilled water (same conditions as for the test material) served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted
Duration of treatment / exposure:
4 hours
Observation period:
1 hour and then 24, 48 and 72 hours after removal of the patch. In case of persistent reactions, additional observations are carried out from Day 4 to Day 14.
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 4 hours

SCORING SYSTEM: E.E.C. regulation compliant

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 48 hours
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 48 hours
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 48 hours
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 72 hours
Score:
0
Irritant / corrosive response data:
No effect was observed at the 1 hour time point, and scores for erythema and edema were all equal to 0 for the three animals of the study.
Only a slight erythema was observed at 24 hours in one animal, at 48 hours in one other animal and at both 24 and 48 hours in the third animal.
Individual mean scores (24, 48 and 72 hours) for erythema and eschar were as follows: 0.3, 0.3 and 0.7.
Individual mean scores (24, 48 and 72 hours) for edema were as follows: 0, 0 and 0.
The Primary Skin Irritation indice determined in compliance with the "Journal Officiel de la Rébublique Française dated February 21st, 1982" was equal to 0.3 (non irritant).
Other effects:
No further results

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this study, the test material is not irritating to the rabbit skin.
Executive summary:

This GLP-compliant study was performed to assess the potential of the test material to induce skin irritation in vivo, according to OECD Guideline 404 (dated July.17th, 1992) and EU method B.4 of the E.E.C. directive n° 92/69 (dated December 29th, 1992).

 

Material and methods

0.5 mL of the test material were applied as supplied, under semi-occlusive dressing during 4 hours, on an undamaged skin area of 3 male rabbits. Skin reactions were recorded 1 hour and then 24, 48 and 72 hours after the patch removal (in case of persistent reactions, additional observations would have been carried out until day 14).

 

Results

At the 1 hour time point, no effect was observed in any animal of the study. The individual mean scores (24, 48 and 72 hours) for erythema and eschar were: 0.3, 0.3 and 0.7, and the individual mean scores (24, 48 and 72 hours) for edema were as follows: 0, 0 and 0.

 

Conclusion

Under the experimental conditions of this study, the test material is no classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Dangerous Substances Directive 67/548/EEC (DSD) criteria.