Registration Dossier

Administrative data

Description of key information

Skin Irritation – not a dermal irritant
Ocular Irritation - not an ocular irritant
Respiratory Irritation - not a repiratory irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin Irritation – C9-C14 Aliphatics (2-25% Aromatics) are not corrosives or dermal irritants for rabbit (OECD TG 404). The average (24, 48, 72 hours) erythema score was found to be 1.22 and the average edema score was 0.3. 

 

Ocular Irritation - C9-C14 Aliphatics (2-25% Aromatics) are not irritating for rabbits (OECD TG 405). The average (24, 48, 72 hours) conjuctivae score was found to be 0.3, the average chemosis score was 0, and there was no indication of iris or cornea irritation (scores of 0). 

 

Respiratory Irritation

Human Exposure - There are no reports of respiratory irritation in humans associated with exposure to C9-C14 aliphatic solvents. Two studies have been reported in which volunteers were exposed to C9-C14 aliphatic solvents at differing concentrations. In the first of these, 6 volunteers were exposed for 15 minutes at levels ranging from 24-470 ppm (126-2468 mg/m3) and, after exposure, asked to report their symptoms. There were no reports of throat irritation at the two lower concentrations and only one of the 6 reported throat irritation at the highest level (Carpenter et al., 1975). In the second study (Lammers et al., 2007), there was no evidence of respiratory irritation in volunteers at levels of 570 mg/m3. 

 

Animal Exposure - In the first of these studies (Carpenter et al., 1975a), a 50% depression in respiratory rate was observed in mice exposed to 10,000 mg/m3 (1700 ppm), but not at 4.4 mg/l (770 ppm). In the second of these studies (ExxonMobil Biomedical Sciences, Inc., 1988), a maximum exposure concentration of 170 ppm (935 mg/m3) produced a respiratory depression of 15%, a response which was considered to be slightly irritating. 

 

Taken as a whole, the animal data suggest that C9-C14 aliphatic solvents are not highly irritating to the respiratory tract and certainly not at occupational levels. The results of the volunteer studies demonstrate that C9-C14 aliphatic solvents are not respiratory irritants to humans.

Justification for classification or non-classification

These findings do not warrant the classification of C9-C14 Aliphatics (2-25% Aromatics) as skin, ocular, or respiratory irritants under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

 

SKIN IRRITATION: Erythema and edema scores (24, 48, and 72 average) are below the classification threshold requirements: 2.0, Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparation; 2.3, the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP)

 

OCULAR IRRITATION: Ocular lesion scores (24, 48, and 72 average) are below the classification threshold requirements.

Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparation: 0, cornea opacity; 0, iris lesion; >2.5, redness of the conjunctivae; >2.0, oedema of the conjunctivae (chemosis).

Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP): 0, cornea opacity; 0, iris lesion; >2.0, redness of the conjunctivae; >2.0, oedema of the conjunctivae (chemosis).

 

RESPIRATORY IRRITATION - There are no studies that warrent classification as a respiratory irritant under either the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC or under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).