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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Propane-1,2-diol, propoxylated
EC Number:
500-039-8
EC Name:
Propane-1,2-diol, propoxylated
Cas Number:
25322-69-4
Molecular formula:
(C3 H6 O)n H2 O n= >1 - <4.5
IUPAC Name:
propylene glycol
Details on test material:
Name: Propane-1,2-diol propoxylated
Molecular weight: Mn = 260 g/mole
Physical state: clear pale yellow liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ORGANISMS: Rabbit New Zealand White
- Source: Hazelton Research Products, Denver, PA, USA
- Age: 8-12 weeks
- Weight at study initiation: 2.324-2.907 kg
- Group size: 5M+5F
- Controls: No

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION: dermal
- Area covered: dorsal area of the trunk of the test animals
- Occlusion: occlusive 24 hour
- Vehicle: none
- Concentration in vehicle: undiluted
- Doses: 3000 mg/kg
- Removal of test substance: with gauze and water
Doses:
3000 mg/kg
No. of animals per sex per dose:
10
Details on study design:
Clinical observations daily, body weights recorded at day 7 and 14, gross necropsy carried out at termination.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
No deaths occurred
Clinical signs:
None
Body weight:
No apparent effect on mean body weight during the study.
Gross pathology:
Unremarkable
Other findings:
Erythema (grade 1) observed in 2/5 males and 2/5 females at 24 hours after application. All test sites were normal 48 hours after application.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for this propoxylated propane-1,2-diol (molecular weight 230) was >3000 mg/kg. There were no clinical signs, transient erythema was observed in 4/10 rabbits. All animals were normal by 48 hours after application.