Registration Dossier

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.