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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

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
Buhler
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
Available data provided by ECHA - study from 1991.

Test material

Constituent 1
Chemical structure
Reference substance name:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
EC Number:
406-176-9
EC Name:
2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol
Cas Number:
79072-96-1
Molecular formula:
C24 H30 O6
IUPAC Name:
1-[2,6-bis(4-ethylphenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Bor. DHPW (SPF)
Sex:
not specified

Study design: in vivo (non-LLNA)

Induction
Route:
other: epicutaneous
Vehicle:
olive oil
Concentration / amount:
2000 mg/kg b.w in 1.0 ml olive oil applied
Challenge
No.:
#1
Route:
other: epicutaneous
Vehicle:
olive oil
Concentration / amount:
2000 mg/kg b.w in 1.5 ml olive oil applied
No. of animals per dose:
20 in test group,
20 in negative control.
Details on study design:
RANGE FINDING TESTS: Maximum concentration not giving rise to irritating effects in the preliminary test: 2000 mg/lg

MAIN STUDY
A. INDUCTION EXPOSURE
Test group: 2000 mg/kg bw in 1.0 ml olive oil (Application: 1.0 ml olive oil)
Control group: Yes

B. CHALLENGE EXPOSURE
- No. of exposures :1
Test group: 2000 mg/kg bw in 1.5 ml olive oil (Application: 1.5 ml olive oil)
Control group: Yes

During inuduction exposure animals were observed for signs of irritation.

After challanged exposure animals were observed at 24 and 48 hrs for evidence of sensitization.
Positive control substance(s):
not specified

Results and discussion

Positive control results:
Not specified

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
2000 mg/kg b.w
No. with + reactions:
0
Total no. in group:
20

Any other information on results incl. tables

Signs of irritation during induction: None

Number of animals showing evidence of sensitization at challenge: None

Group

Challenge Concentration

Number of animals showing skin reactions after challenge

24 h

48 h

Test Group

2000 mg/kg

0/20

0/20

Control Group

 

0/20

0/20

Other Observations: No change in body weight was caused by the test substance.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material did not show any evidence of sensitisation in guinea pigs following induction and challenge at 2000 mg/kg bw.
0 of 20 animals (test and control groups) showed positive reactions for skin sensitization after challenge exposure.