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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2011-06-03 to 2011-06-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study; GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(1r,4r)-N1,N1,N4,N4-tetrakis(2-hydroxyethyl)cyclohexane-1,4-dicarboxamide
EC Number:
700-597-4
Cas Number:
1215841-86-3
Molecular formula:
C16H30N2O6
IUPAC Name:
(1r,4r)-N1,N1,N4,N4-tetrakis(2-hydroxyethyl)cyclohexane-1,4-dicarboxamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
CAS name: 1,4-Cyclohexanedicarboxamide, N1,N1,N4,N4-tetrakis(2-hydroxyethyl)-, trans
Chemical characterization: Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide
Characteristics: Whitish, solid, powder, hydroscopic
Contents:
91.53 % Trans-N,N,N',N'-Tetrakis(2-hydroxyethyl)-cyclohexyl-1,4-diamide

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS: 
- Source: LPT, Laboratory of Pharmacology and Toxicology, Löhndorf (Germany)
- Sex: male
- Age: approx. 5.5 - 6.5 months
- Weight at study initiation: 2.5 kg to 2.6 kg
- Housing: single
- Diet: ad libitum, ssniff K-H (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water: ad libitum, tap water
- Acclimatisation period: at least 20 days
- Controls: untreated skin surrounding the application area
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3 °C
- Humidity (%): 30% - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/12 hour dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg/patch and animal
1000 mg of the test item were mixed with 0.5 mL aqua ad iniectabilia , 750 mg of this paste were applied per animal (500 mg test item/animal)
Duration of treatment / exposure:
4 hour(s)
Observation period:
Postexposure period: 72 hours (Because no effects have been observed the period of observation is not 14 days but 72 hours.)
Number of animals:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: 1000 mg of the test item were mixed with 0.5 mL aqua ad iniectabilia , 750 mg of this paste were applied per animal
(500 mg test item/animal)
- Area of exposure: dorsal area of trunk, shaved 24 hours in advance,  approx. 6 cm2
- Vehicle: aqua ad iniectabilia
- Concentration: 500 mg test substance 
- Occlusion: gauze patch held in place by semi-occlusive non-irritating  tape dressing
- Washing:
EXAMINATIONS
- Examination time points: 60 minutes, 24, 48, 72 hours,
- Scoring system: Draize (0-4 possible scores each for erythema/eschar  and for edema)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
AVERAGE SCORE
- Erythema: 0
- Edema: 0
Other effects:
no other effects

Any other information on results incl. tables

Findings           Examination                  Skin irritation scores

of the skin       schedule                      

animal no.

1             2            3

E/Oe          E/Oe        E/Oe

          500 mg substance/patch/animal

 

erythema and

eschar formations/before dosing        0/0          0/0 0/0

oedema formation

time after removal

of the patch

(4-hour exposure)

60 min      0/0            0/0          0/0

24 hours    0/0            0/0          0/0

48 hours    0/0           0/0          0/0

72 hours    0/0            0/0          0/0

 

0   no pathological findings    

E   erythema and eschar formations 

Oe  oedema

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
According to the EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide was n o n - i r r i t a t i n g to skin, hence, no labelling is required.
Executive summary:

The purpose of this study was to examine trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide for acute dermal irritation/corrosion properties in rabbits (patch test), according to OECD guideline 404, EC method B.4.and OCSPP guideline 870.2500.

Under the present test conditions, none of the three male rabbits exposed for 4 hours to 500 mg trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide/patch (semi-occlusive conditions) showed any skin reaction. There were no systemic intolerance reactions. Therefore, the test item was non-irritating to skin, hence no labelling is required.