Registration Dossier

Administrative data

Description of key information

Skin irritation: irritating

Eye irritation: irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Principles of method if other than guideline:
Primary skin irritation was recorded in a 10-grade ordinal series and is based upon the severest reaction that developed on the clipped skin of each 5 albino rabbits within 24 hours of the uncovered application of undiluted sample or of solutions in water, propylene glycol, or acetone.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: undiluted sample or solutions in water, propylene glycol or acetone
Controls:
not specified
Amount / concentration applied:
0.01 mL (undiluted)
Duration of treatment / exposure:
24 hour(s)
Observation period:
no data
Number of animals:
5 animals
Details on study design:
SCORING SYSTEM:
- Method of calculation: Primary skin irritation was recorded in a 10-grade ordinal series and is based upon the severest reaction that developed on the clipped skin; Grade 1: indicated no irritation, Grade 2: least visible capillary injection from the undiluted chemical; Grade 3: strong capillary injection; grade 4: slight erythema; Grade 5: strong erythema, edema or slight necrosis; Grade 6: indicated necrosis when undiluted, Grade 10: indicated necrosis from a 0.01% solution;
Remarks on result:
other:
Remarks:
The primary skin irritation was graded as 2.
Irritant / corrosive response data:
The primary skin irritation was graded as 2.
Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the Harmonised classificatation Annesx VI of Regulation (EC) No 1272/2008 (CLP Regulation) the substance is classified as skin irritating cat. 2 (H315).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
Principles of method if other than guideline:
Eye injury in rabbits is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemical.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
other: undiluted sample or solutions in water or propylene glycol
Amount / concentration applied:
several amounts starting at 500μL (based on Carpenter et al., 1946, Chemical Burns of the Rabbit Cornea. Am.J.Opthal. 29:1363)
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
no data (usually 5)
Details on study design:
SCORING SYSTEM: Grade 1 indicates at most a very small area of necrosis resulting from 0.5 ml of undiluted chemical in the eye. Grade 5 indicates a so-called severe burn f rom 0.005 ml, and Grade 10 indicates a severe burn from 0.5 ml of a 1% solution in water or propyene glycol.
Remarks on result:
other: The primary eye irritation was graded as 2.
Irritant / corrosive response data:
The primary eye irritation was graded as 2. This corresponds to 0.5 ml of undiluted test substance resulting in a score between 1 and 5.
Interpretation of results:
study cannot be used for classification
Conclusions:
Based on the Harmonised classificatation Annesx VI of Regulation (EC) No 1272/2008 (CLP Regulation) the substance is classified as irritating to eyes cat. 2 (H319).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The available studies for skin and eye irritation are not suitable to draw a final conclusion concerning C&L, due to missing detailed information. However, the results provide an indication of an slight skin and eye irritating potential, which support the classification according to Regulation (EC) No 1272/2008 as skin and eye irritanting.

Primary skin irritation was recorded in a 10-grade ordinal series and is based upon the severest reaction that devoleoped on the clipped skin of each 5 albino rabbits within 24 hours of the unvovered application of undiluted sample or of solutions in water, propylene glycol or acetone. The primary skin irritaion grade was 2, most propably resulting from capillary injection of the undiluted chemical (Smyth, 1949).

Eye injury in rabbits is recorded in a 10-grade ordinal series and is based upon the degree of corneal necrosis that results from instillation of various volumes and concentrations of chemicals. The primary eye irritation was graded as 2. This corresponds to 0.5 ml of undiluted test substance resulting in a score between 1 and 5 (Smyth, 1949).

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 Annex VI Table 3.1, 1,1-diethoxyethane is classified as skin irritating cat 2 (H315) and eye irritating cat 2 (H319), respectively.