Hexachloroethane

Skin sensitisation

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

Reference

Reference 1

Reference Type:

other: Published toxicological report

Title:

Unnamed

Year:

2011

Reference 2

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 3

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 4

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

Test material information

Constituent 1

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.