Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-04-15 to 1996-05-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1987)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
(1992)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
2,2,4(or 2,4,4)-trimethyl-1,6-hexanediol of Hüls AG
purity 94.6 % (GC-FID area)
batch No. Pt. 15570/3033 of August 1995; sample ID 0637/81 770

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, 33176 Borchen, Germany
- Strain: HsdCpb: WU (SPF)
- Sex. male and female
- Weight at study initiation: male: 251-274 g, female: 209-233 g
- Housing: single
- Diet (e.g. ad libitum): Ssniff R 10, Ssniff Spezialfutter GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / light rhythm

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION: 
- Area covered: dorsolumbar region, approximately 10 % of the body surface
- Doses: single dose, 2.110 ml/kg bw
- Occlusion: gauze dressing fixed with Acrylastic bandage (semiocclusive)
- Removal of test substance: after 24 hours with corn oil (MEH 56) and  cellulose
- At first test item were administrated to 2 male and 2 femal rats, there were no mortality after 24 hours, test item were administrated to 3 male and 3 female rats
Duration of exposure:
24 hours
Doses:
single dose: 2.110 ml/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
EXAMINATIONS: 
- Clinical signs, mortality: 1/2, 1, 2, 3, 4, 5, and 6 hours after  treatment, once daily for next 2 weeks
- Dermal response: Daily after patch removal
- Body weights: days 0, 7, and 14
- Macroscopic examination: day 14 (all animals)
Statistics:
not required

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occurred.
Clinical signs:
No signs of toxicity were observed. No erythema or edema  were observed from patch removal to end of study.
Body weight:
Body weight gain was not affected.
Gross pathology:
No macroscopic changes in organs, skin, or  subcutaneous tissue were found.
Other findings:
no other findings

Any other information on results incl. tables

no other information

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study the LD50 of the acute dermal toxicity on male and female rats is above 2000 mg/kg of body weight for the test item in rats.
Executive summary:

The test item was applicated at the skin of the male and female rats in a dose of 2000 mg/kg body weight

to obtain information on the toxicity, in particular lethality, of the test item.

The test item was administrated dermal to 5 male and 5 female WISTAR rats.

No mortalities were observed at this dose. No signs of toxicity were observed. No erythema or edema  were observed from patch removal to end of study.

Body weight gain was not affected.

No macroscopic changes in organs, skin, or  subcutaneous tissue were found.

Hence the LD50 of the acute dermal toxicity on male and female rats is above 2000 mg/kg of body weight for the test item in rats.