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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
EPA 40 CFR parts 792 and 160, FDA 21 CFR 58

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): c-4000
- Physical state: liquid
- Analytical purity: >99%
- Purity test date: 2007-02-26
- Lot/batch No.: jyc0367
- Expiration date of the lot/batch: 2007-08-26
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
The test article was kept in contact with the skin for 4 hours.
Observation period:
The test sites were scored for dermal irritation at 60 minutes after patch removal. Reactions were scored again at 24, 48 and 72h following patch removal.
Number of animals:
The test article was applied to 3 rabbits, 2 males and 1 female.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hour
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.42

Any other information on results incl. tables

Erythema was absent to very slight at 60 minutes after patch removal and at 24 and 48 hours. Erythema was absent at 72 hours.

Edema was absent to very slight at 60 minutes after patch removal and absent at 24,48,72 hours.

There were no abnormal physical signs noted during the observation period.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
C-4000 is a dermal irritant in rabbits but not classified according to EEC criteria (mean erythrema or edema scores are below 2) .
Executive summary:

In an acute dermal toxicity study, groups of three healthy New Zealand White rabbits (2 males, 1 female) were dermally exposed to c-4000 (>99%) for 4 hours to a 2.5x2.5 cm patch at doses of   0.5 ml/site.  Animals then were observed for 4 days.

No mortality occurred (limit test)

C-4000 is of LOW Toxicity based on males or females.

There were no major treatment related clinical signs, necropsy findings or changes in body weight.