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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 September 1978 to 20 November 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an accepted and published method of the time. The study was conducted prior to modern GLP requirements.

Data source

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

Materials and methods

Principles of method if other than guideline:
The procedure followed was essentially that of Draize:Draize, J.H., Woodward, G. and Calvery, H.O. "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", J. Pharm. and Ex. Ther. 82, 377 (1944).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrahydrofuran- Lot/batch No.: Sample No. 7427-F- Other: Received from GAF Corporation on August 25, 1978

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
- Source: Summit View Farm, Belvedere, New Jersey (USA)- Housing: maintained under standard laboratory conditions- Diet (ad libitum): Wayne animal feeds- Water (ad libitum): source not stated- Acclimation period: 7 days prior to test chemical administration

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and non-abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL - single exposure
Duration of treatment / exposure:
72 hours
Observation period:
24 and 72 hour observations
Number of animals:
6, mixed sex
Details on study design:
A 0.5 mL aliquot of the test material was applied to clipped areas of intact and abraded skin. The abrasions were longitudinal epidermal incisions sufficiently deep to penetrate the stratum corneum, but not so deep as to destroy the integrity of the derma. Applications were made under occlusive patches (2" x 2" gauze, covered by adhesive tape). Following applications, the entire trunk of each animal was covered with an impermeable occlusive wrapping. Wrappings were removed after 24 hours following application. The sites were individually examined and scored separately for erythema and edema at 24 and 72 hours. The mean scores for 24 and 72 hours were averaged to determine a final irritation index.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
1.93
Remarks on result:
other: Primary irritation index
Irritant / corrosive response data:
The results are summarized in Table 1.

Any other information on results incl. tables

Table 1: Primary Skin Irritation - Rabbits

   Hours: 24     72   
 Rabbit Number  Skin  Erythema  Edema  Erythema  Edema
 1  NA  1  2  1  2
   A  1  2  1  2
 2  NA  1  0  0  0
   A  1  0  1  0
 3  NA  1  0  1  2
   A  1  0  1  1
 4  NA  0  0  1  1
   A  0  0  1  1
 5  NA  1  2  0  0
   A  2  3  2  2
 6  NA  1  1  1  1
   A  1  1  1  1
 Average  NA  0.8  0.8  0.7  1.0
   A  1.0  1.0  1.2  1.2

Combined Average = 7.7

Primary Irritation Index = 1.93

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: other: under the EU DSD classification criteria (EU Directive 67/548/EEC)
Conclusions:
Tetrahydrofuran was not judged to be a primary dermal irritant in rabbits under the conditions of this study. The calculated primary irritation index was 1.93.Tetrahydrofuran would not be rated as irritating under the EU DSD classification criteria (EU Directive 67/548/EEC) or EU CLP classification criteria (EU Regulation 1272/2008).
Executive summary:

Six albino rabbits of mixed sex were treated under occlusive wrap with 0.5 mL of tetrahydrofuran in a single application. Areas of abraded and non-abraded skin were treated. The Primary Irritation Index (Draize method) was reported as 1.93. Tetrahydrofuran was not considered a primary dermal irritant in rabbits under the conditions of this study.