Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07-21 October 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study has been performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of 5,11,17,23-tetra-tert-butyl-25, 26, 27, 28-tetrahydroxy- 2,8,14,20-tetrasulfonyl [19.3.1.13,7.19,13.115,19]octacosa- 1(25),3,5,7(28),9,11,13(27),15,17,19(26),21,23-dodecaene and 5,11,17,23,29,35,41,47-octa-tert-butyl- 49,50,51,52,53,54,55,56-octahydroxy-2,8,14,20,26,32,38,44- octasulfonyl[43.3.1.13,7.19,13.115,19.121,25.127,31.133,37.1 39,43]hexapentaconta- 1(49),3,5,7(56),9,11,13(55),15,17,19(54),21,23,25(53),27,29, 31(52),33,35,37(51),39,41,43(50),45,47-tetracosaene
IUPAC Name:
Reaction mass of 5,11,17,23-tetra-tert-butyl-25, 26, 27, 28-tetrahydroxy- 2,8,14,20-tetrasulfonyl [19.3.1.13,7.19,13.115,19]octacosa- 1(25),3,5,7(28),9,11,13(27),15,17,19(26),21,23-dodecaene and 5,11,17,23,29,35,41,47-octa-tert-butyl- 49,50,51,52,53,54,55,56-octahydroxy-2,8,14,20,26,32,38,44- octasulfonyl[43.3.1.13,7.19,13.115,19.121,25.127,31.133,37.1 39,43]hexapentaconta- 1(49),3,5,7(56),9,11,13(55),15,17,19(54),21,23,25(53),27,29, 31(52),33,35,37(51),39,41,43(50),45,47-tetracosaene
Details on test material:
- Name of test material (as cited in study report): TC4ASO2
- Substance type: multi-constituent
- Physical state: white powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 95% 4-tert-Butylsulfonylcalix(4)arene (CAS 204190-49-8)
5% 4-tert-Butylsulfonylcalix(8)arene
- Lot/batch No.: AYUI-2Y
- Expiration date of the lot/batch: 08 July 2009
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 8 weeks old
- Weight at study initiation: males: 234-261 g; females: 166-176 g
- Fasting period before study: no
- Housing: Individually housed in labeled Macrolon cages (MIII type, height 18 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.8 – 21.2
- Humidity (%): 43 - 72
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
propylene glycol
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 25 cm² for males and 18 cm² for females
- % coverage: approx. 10% of the total body surface
- Type of wrap if used: surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg BW
- Concentration (if solution): 2000 mg/kg BW
- The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.


VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 10 mL/kg BW
Duration of exposure:
24 hours
Doses:
2000 mg/kg BW
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: twice daily; Body weights: Days 1 (pre-administration), 8 and 15; Clinical signs: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.
Clinical signs:
Flat posture and chromodacryorrhoea were noted among the animals on Days 1 and/or 2. Piloerection was noted in all animals between Days 1 and 4.
Scales and scabs were seen in the treated skin-area among the animals throughout the observation period.
Body weight:
The body weight gain during the observation period was within the range expected for rats used in this type of study.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 value of TC4ASO2 in Wistar rats was established to exceed 2000 mg/kg body weight.

Based on these results TC4ASO2 does not have to be classified and has no obligatory labeling requirement for dermal toxicity according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007) and EC criteria for classification and labeling requirements for dangerous substance and preparations (Council Directive 67/548/EEC).