Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1978 before the development and validation of the LLNA.

Test material

Constituent 1
Chemical structure
Reference substance name:
1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
EC Number:
204-077-3
EC Name:
1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
Cas Number:
115-27-5
Molecular formula:
C9H2Cl6O3
IUPAC Name:
1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
Details on test material:
- Name of test material (as cited in study report): Chlorendic anhydride- Analytical purity: 93.81%- Lot/batch No.: 3-12-206

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS- Source: - Age at study initiation: - Weight at study initiation: 418 to 587 g- Housing: Suspended metal cages- Diet: Purina Rabbit Chow, ad libitum and cabbage 3 times per week.- Water: ad libitum- Acclimation period: 21 daysENVIRONMENTAL CONDITIONS- Temperature (°C): - Humidity (%): - Air changes (per hr): - Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Sodium chloride solution.
Concentration / amount:
0.9%
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: Sodium chloride solution.
Concentration / amount:
0.9%
No. of animals per dose:
8
Positive control substance(s):
yes
Remarks:
2,4-Dinitro-1-Chlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1 ml
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1 ml. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Wheal and flare.
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 ml
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 ml. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Wheal and flare.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 ml
No. with + reactions:
5
Total no. in group:
8
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 5.0. Total no. in groups: 8.0. Clinical observations: Wheal and flare.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 ml
No. with + reactions:
2
Total no. in group:
8
Clinical observations:
Wheal and flare
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 ml. No with. + reactions: 2.0. Total no. in groups: 8.0. Clinical observations: Wheal and flare.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Based upon the results obtained the test compound would be considered a possible sensitizing agent in man.