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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
no negative/vehicle control included in the study

Data source

Referenceopen allclose all

Reference Type:
other: Published toxicological report
Title:
Unnamed
Year:
2011
Reference Type:
other: Published toxicological report
Title:
Toxicological Profile for Hexachloroethane
Author:
Agency for Toxic Substances and Disease Registry (ATSDR)
Year:
1997
Bibliographic source:
Not reported
Reference Type:
publication
Title:
The toxicity of hexachloroethane in laboratory animals.
Author:
Weeks MH, Angerhofer RA, Bishop R, Thomasino J, Pope CR.
Year:
1979
Bibliographic source:
Am Ind Hyg Assoc J. 1979 Mar;40(3):187-99. doi: 10.1080/15298667991429499. PMID: 495459.
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: determine the skin sensitisation potential of the test material by intradermal dosing guinea pigs, and monitoring of skin reactions.
- Short description of test conditions: the test material was injected by intradermal route to guinea pigs ten times during 3 weeks (induction) followed by a single injection after a 2-week rest period (challenge). Ten guinea pigs were exposed. A positive control was included. Skin sensitising reactions were monitored over a 48-h observation period.
- Parameters analysed / observed: not specified
GLP compliance:
not specified
Type of study:
not specified
Justification for non-LLNA method:
The LLNA method was not available yet by the time the study was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexachloroethane
EC Number:
200-666-4
EC Name:
Hexachloroethane
Cas Number:
67-72-1
Molecular formula:
C2Cl6
IUPAC Name:
hexachloroethane
Test material form:
solid: crystalline
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Hummel Chemical Company, specifications MIL-H-235B, national stock number 6810-00-N00-001
- Purity: technical grade, 99.8%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Housing: housed in suspended wire cages
- Diet: ad libitum, commercial chow (Zeigler)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 24 ± 2°C
- Humidity: 45-55%
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
other: propylene glycol/normal saline (1:29 v/v)
Concentration / amount:
0.1% (w/v)
Day(s)/duration:
3-week exposure period (ten injections) followed by a 2-week rest
Challenge
No.:
#1
Route:
intradermal
Vehicle:
not specified
Concentration / amount:
0.1%
No. of animals per dose:
10
Details on study design:
FINAL SCORES
> 100 - Strong sensitising
25 - 100 - Mild sensitising
< 25 - No sensitising
Challenge controls:
Ten positive control guinea pigs received and were challenged with a 0.1% suspension of DNCB.
Positive control substance(s):
yes
Remarks:
0.1% suspension of dinitrochlorobenzene (DNCB)

Results and discussion

In vivo (non-LLNA)

Results
Key result
Remarks on result:
other: see results in the table below

Any other information on results incl. tables














































































 



Mean body weight (g)



Mean irritation scores



 



Diluent



Test compound



24 hrs



Initial



Final



Initial



Final



Initial



Final



Test compound



258 ± 27



452 ± 28



0



0



0.8



0.4



Positive control



294 ± 31



494 ± 43



0



0



19 ± 11



341 ± 85



 



 



 



 



 



 



 



48 hrs



 



 



 



 



 



 



Test compound



-



-



0



0



0



0.2



Positive control



 



 



0



0



5 ± 3



230 ± 88



 


Test compound did not produce a sensitisation reaction in guinea pigs.


DNCB positive control showed a sensitising reaction in 10/10 guinea pigs.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the test conditions applied, the test material produced no skin sensitisation in guinea pigs.
Executive summary:

Skin sensitisation was evaluated in guinea pigs (males). 


Intradermal injection of 0.1% suspension (w/v) of hexachloroethane or of a 0.1% suspension of dinitrochlorobenzene (DNCB), a known sensitiser, in a mixture containing propylene glycol/normal saline (1:29 v/v) were administered to guinea pigs (males).


Ten test guinea pigs received and were challenged with a 0.1% suspension of hexachloroethane. Ten positive control guinea pigs received and were challenged with a 0.1% suspension of DNCB. Positive control (DNCB) produced sensitisation in 10 of 10 guinea pigs. Challenge dose of hexachloroethane (last intradermal injection after a 2-week rest period) produced no greater response than did the initial injection. Test compound did not sensitise guinea pigs.