DL-hexane-1,2-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

March & April 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study fulfills scientific principles and was conducted according to OECD 402 (1981) but pre-dates GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentane-1,2-diol

EC Number:

226-285-3

EC Name:

Pentane-1,2-diol

Cas Number:

5343-92-0

IUPAC Name:

pentane-1,2-diol

Constituent 2

Reference substance name:

1,2-pentanediol

IUPAC Name:

1,2-pentanediol

Test material form:

other: liquid

Details on test material:

CGA 143816 techn.
Purity 95.0%
Batch No EN 31622

Test animals

Species:

rat

Strain:

other: TIF:RAIf(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
Initial Body Weight Range: 184-214 g
Initial Age: 7-8 weeks
Individual Identification: By cage number
Husbandry: The animals were kept under conventional laboratory conditions. They were caged individually in Macrolon cages type 2 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin). The animal room was air conditionned: temperature 22 ±3 ° C, relative humidity 55 ±15%, 12 hours light/day, approximately 15 air changes/h.
Diet: Rat food, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), and water were provided ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Volume (ml/kg body weight) applied: 2
Pretreatment: The animals were allocated to the different dose groups by random selection. Approximately 24 hours before treatment an area on the back of the rat of at least 10% of the body surface was shaved with an electric clipper.
Administration: The required amount of the test substance was evenly dispersed on the skin.It was covered with a gauze lined occlusive dressing, which was fastened around the trank with an adhesive elastic bandage. After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water. Thereafter the reaction of the skin was appraised repeatedly.
Observation Period: 14 days or until all symptoms have disappeared, whichever lasts longer

Duration of exposure:

24 hours exposure and 14 days observation period

Doses:

2 mL /kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not required

Details on study design:

Mortality was checked twice dails during working days and symptoms were recorded once daily, Body weight was recorded at days 1, 7, 14 and at death (if applicable).

Statistics:

From the Body weights, the group means and their standard deviations were calculated.
Where feasable, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J. Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in this study during exposure and observation period.

Clinical signs:

other: Systemically no specific symptoms were seen. At the application site, slight erythema, which lasted for three days, was present.

Gross pathology:

At autopsy no compound related gross organ changes were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

1,2-Pentanediol caused no mortality and only weak fully reversible erythema upon dermal application of 2000 mg/kg bw. Thus the LD50 was set to > 2000 mg/kg bw in this study.

Executive summary:

10 rats (5 male and 5 female) were dermally exposed to 2000 mg/kg bw 1,2-pentanediol for 24 hours occlusively and thereafter observed for 14 days according to OECD 402. No Clinical signs and symptoms were noted except erythemy which fully reversed within three days. No mortality was observed and weight gain was seen in males and females. At autopsy no treatment-related observations were recorded.

Thus, in this limit test no significant toxicity was observed and the LD50 was set to >2000 mg/kg bw.