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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Guideline study, non GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Cyclohexane, oxidized, aquous extract
IUPAC Name:
Cyclohexane, oxidized, aquous extract
Constituent 2
Reference substance name:
Cyclohexane, oxidized, aq. ext.
EC Number:
272-810-4
EC Name:
Cyclohexane, oxidized, aq. ext.
Cas Number:
68915-38-8
IUPAC Name:
68915-38-8
Details on test material:
- Name of test material (as cited in study report): Abstreifsaeure
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
16.7% Adipinic acid (CAS-Nr. 12404-9)
13.2% 6-Hydroxycaproic acid (CAS-Nr.1191-25-9)
2.1% Glutaric acid (CAS-Nr. 110-94-1 )
0.8% succinic acid (CAS-Nr. 13392-69-3)
0.2% valeric acid (CAS-Nr. 109-52-4)
0.2% butanoic acid (CAS-Nr. 107-92-6)
0.1% propionic acid (CAS-Nr. 79-09-4)
0.3% acidic acid (CAS-Nr. 64-19-7)
1.4% formic acid (CAS-Nr. 64-18-6)
10% polymeric oxycaproic acid
~20ppm cobalt0.2% valeric acid

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Mean weight at study initiation: male 2.82 Kg
- Housing: one per cage
- Diet: Kliba 341, about 130 g/animal/day
- Water: 250 ml tap water/animals/day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml undiluted (after heating at about 50 °C)
Duration of treatment / exposure:
4 hour(s)
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 h


SCORING SYSTEM: Draize scoring. Readings were taken 30-60 min after removal of the test patches, and 24h, 48h and 72h after the beginning of the application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
No signs of erythema or edema were observed at any time point

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating